510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD March 2016 TOTAL 510(k)s THIS PERIOD 279 TOTAL WITH SUMMARIES 265 TOTAL WITH STATEMENTS 14
DEVICE: QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument ORION DIAGNOSTICA OY 510(k) NO: K142993(Traditional) ATTN: ANJA KONTIO PHONE NO : 358 509665917 KIVIHARJUNTIE 11 4B SE DECISION MADE: 10-MAR-16 OULU FI 90220 510(k) STATEMENT DEVICE: Flight 60 Ventilator FLIGHT MEDICAL INNOVATIONS LTD. 510(k) NO: K143035(Traditional) ATTN: Yanir Shaked PHONE NO : 972 8 9235111 13 HAMELACHA STREET NORTH INDUSTRISE DECISION MADE: 30-MAR-16 LOD IL 71520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QbCheck QBTECH AB 510(k) NO: K143468(Traditional) ATTN: Hans Bostrom PHONE NO : 46 706 339209 Kungsgatan 29 SE DECISION MADE: 22-MAR-16 Stockholm SE 11156 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: xevonta dialyzer B. Braun Avitum AG 510(k) NO: K143482(Traditional) ATTN: Giuliana Gavioli PHONE NO : 39 0535 616757 Am Buschberg 1 SE DECISION MADE: 01-MAR-16 Melsungen DE D-34212 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VisuCon-F Low Fibrinogen Control Plasma AFFINITY BIOLOGICALS INC. 510(k) NO: K150144(Traditional) ATTN: Denise Foulon PHONE NO : 905 3049896 1395 SANDHILL DRIVE SE DECISION MADE: 06-MAR-16 ANCASTER CA L9G 4V5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Oniris SAS Oniris 510(k) NO: K150566(Traditional) ATTN: Thibault Vincent PHONE NO : 33 147 505070 704 Avenue Roger Salengro SE DECISION MADE: 21-MAR-16 CHAVILLE FR 92370 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OVA1 Next Generation VERMILLION, INC. 510(k) NO: K150588(Traditional) ATTN: Benjamin A Kimball PHONE NO : 1 512 5190435 12117 BEE CAVES RD., BLDG III, SUISE DECISION MADE: 18-MAR-16 AUSTIN TX 78738 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Exceed Tx GREAT LAKES ORTHODONTICS, LTD. 510(k) NO: K150702(Traditional) ATTN: DAVE GRAVER PHONE NO : 716 8711161 250 200 COOPER AVE SE DECISION MADE: 24-MAR-16 TONAWANDA NY 14150 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medline Epidural Catheter MEDLINE INDUSTRIES, INC. 510(k) NO: K150731(Traditional) ATTN: Matt Clausen PHONE NO : 847 6434785 ONE MEDLINE PLACE SE DECISION MADE: 07-MAR-16 MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAUT-E, SPINAUT-I IMEDICOM CO., LTD. 510(k) NO: K150789(Traditional) ATTN: Bonngu Ha PHONE NO : 82 31479 1156 #612, 172, LS-ro SE DECISION MADE: 01-MAR-16 Gunpo-si KR 435-824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bead Block BIOCOMPATIBLES UK LTD 510(k) NO: K150876(Traditional) ATTN: PEDRO GARCIA PHONE NO : 44 01252 732732 CHAPMAN HOUSE, WEYDON LANE SE DECISION MADE: 07-MAR-16 FARNHAM, SURREY GB GU9 8QL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAUT-P IMEDICOM CO., LTD. 510(k) NO: K150915(Traditional) ATTN: BONGGU HA PHONE NO : 82 31 4791156 #612, 172, LS-RO SE DECISION MADE: 18-MAR-16 GUNPO-SI KR 435-824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Finger Type Pulse Oximeter TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K151024(Traditional) ATTN: C. W. CHEN PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD., WUGU SE DECISION MADE: 02-MAR-16 NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film Pac-Dent International, Inc. 510(k) NO: K151123(Traditional) ATTN: Wenying Zhu PHONE NO : 909 83908888 670 Endeavor Circle SE DECISION MADE: 03-MAR-16 Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 621/624 BIOMAGNETOMETER TRISTAN TECHNOLOGIES, INC 510(k) NO: K151135(Traditional) ATTN: KEVIN PRATT PHONE NO : 858 5502700 6191 CORNERSTONE CT., STE 107 SE DECISION MADE: 15-MAR-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARMONIC HOOK ETHICON ENDO-SURGERY, LLC 510(k) NO: K151136(Traditional) ATTN: MARJORIE MEDINA PHONE NO : 787 7186654 475 CALLE C SE DECISION MADE: 04-MAR-16 GUAYNABO PR 00969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Puritan Bennett 840 Series Ventilator System Covidien LP 510(k) NO: K151252(Traditional) ATTN: Kelsey Lee PHONE NO : 303 3052760 6135 Gunbarrel Ave SE DECISION MADE: 29-MAR-16 Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAUT-V, SPINAUT-S, SPINAUT-I IMEDICOM CO., LTD. 510(k) NO: K151268(Traditional) ATTN: BONGGU HA PHONE NO : 82 31 4791156 #612, 172, LS-ro SE DECISION MADE: 16-MAR-16 Gunpo-si KR 435-824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BellaFuse Hans Biomed Corp. 510(k) NO: K151271(Traditional) ATTN: Lucy Choi PHONE NO : 82 2 4662266 64,Yuseong-Daero 1628Beon-Gil, YusSE DECISION MADE: 11-MAR-16 Daejeon KR 305-811 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arthrex SwiveLock Anchors ARTHREX, INC. 510(k) NO: K151342(Traditional) ATTN: David L. Rogers PHONE NO : 239 6435553 71924 1370 CREEKSIDE BOULEVARD SE DECISION MADE: 24-MAR-16 NAPLES FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines Salter Labs 510(k) NO: K151421(Traditional) ATTN: Mara Caler PHONE NO : 760 7957094 2365 Camino Vida Roble SE DECISION MADE: 10-MAR-16 Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDICOR CA300/CC100 Analyzer with SDB INOVISE MEDICAL, INC. 510(k) NO: K151433(Traditional) ATTN: Earl Anderson PHONE NO : 503 4313800 8770 SW NIMBUS AVENUE SUITE D SE DECISION MADE: 18-MAR-16 BEAVERTON OR 97008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hybernite RT PLASTIFLEX GROUP NV 510(k) NO: K151461(Traditional) ATTN: RAF VAN ROY PHONE NO : 32 01143 5800 BEVERLOOSESTEENWEG 99 SE DECISION MADE: 24-MAR-16 PAAL-BERINGEN BE 3583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor CARETAKER MEDICAL, LLC 510(k) NO: K151499(Traditional) ATTN: JEFF POMPEO PHONE NO : 434 4091945 3042 BERKMAR DRIVE SUITE A SE DECISION MADE: 18-MAR-16 CHARLOTTESVILLE VA 22901-1455 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula Salter Labs 510(k) NO: K151506(Traditional) ATTN: Mara Caler PHONE NO : 760 7957094 2365 Camino Vida Roble SE DECISION MADE: 11-MAR-16 Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ImmuLisa Enhanced Centromere Antibody ELISA IMMCO DIAGNOSTICS, INC. 510(k) NO: K151559(Traditional) ATTN: KEVIN LAWSON PHONE NO : 716 4915452 60 PINEVIEW DR. SE DECISION MADE: 11-MAR-16 BUFFALO NY 14228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Straumann RN Gold Abutment for Bridge STRAUMANN USA, LLC 510(k) NO: K151590(Traditional) ATTN: CHRISTOPHER KLACZYK PHONE NO : 978 7472575 60 MINUTEMAN ROAD SE DECISION MADE: 04-MAR-16 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Family of Steam Sterilizers B 28 series CEFLA S.C. 510(k) NO: K151597(Traditional) ATTN: SILVIA SANSAVINI PHONE NO : 39 542 653438 VIA SELICE PROVINCIALE 23/A SE DECISION MADE: 04-MAR-16 IMOLA IT 40026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NewTom VGi evo QR S.r.l. 510(k) NO: K151612(Traditional) ATTN: LORENZO BORTOLOTTI PHONE NO : 39 0542 643496 Via Silvestrini 20 SE DECISION MADE: 31-MAR-16 Verona IT 37135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUSTAIN Additional Implants GLOBUS MEDICAL INC. 510(k) NO: K151665(Traditional) ATTN: KELLY J BAKER PHONE NO : 610 9301800 1670 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 16-MAR-16 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: chromID MRSA bioMerieux, Inc. 510(k) NO: K151688(Traditional) ATTN: Jewell Coulson PHONE NO : 314 7317342 595 Anglum Rd. SE DECISION MADE: 11-MAR-16 Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MetaNeb 4 System Hill-Rom Services Pte Ltd 510(k) NO: K151689(Traditional) ATTN: Huifang Zhu PHONE NO : 65 649 97395 1 Yishun Ave 7 SE DECISION MADE: 17-MAR-16 Singapore SG 768923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Gammex PI Hybrid Surgical Gloves ANSELL HEALTHCARE PRODUCTS, LLC 510(k) NO: K151694(Traditional) ATTN: Vasudev Dobariya PHONE NO : 732 3455317 111 Wood Avenue South, Suite 210 SE DECISION MADE: 09-MAR-16 Iselin NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEAUTIFIL II Gingiva SHOFU DENTAL CORPORATION 510(k) NO: K151700(Traditional) ATTN: MAURO MALZYNER PHONE NO : 760 7363277 1225 STONE DRIVE SE DECISION MADE: 02-MAR-16 SAN MARCOS CA 92078 510(k) STATEMENT DEVICE: Specular Microscope CEM- 530 NIDEK CO., LTD. 510(k) NO: K151706(Traditional) ATTN: YONEJI MIZUNO PHONE NO : 011 81 533676611 34-14 MACHAMA, HIROISHI-CHO SE DECISION MADE: 17-MAR-16 GAMAGORI JP 443-0038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RECON system - Compression Screws NORMED MEDIZIN-TECHNIK GMBH 510(k) NO: K151708(Traditional) ATTN: ARNE BRIEST PHONE NO : 49 7461 93430 ULRICHSTRASSE 7 SE DECISION MADE: 02-MAR-16 TUTTLINGEN DE D-78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Slim UP ULTRA AIME MEDICAL INC 510(k) NO: K151722(Traditional) ATTN: PAUL GUILBAUD PHONE NO : 1 727 2866227 1258 WEST BAY DRIVE, SUITE F SE DECISION MADE: 18-MAR-16 LARGO FL 33770 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL CARE Disposable PVC Nelaton Catheter SHAOXING FUQING HEALTH PRODUCTS CO510(k) NO: K151745(Traditional) ATTN: DEAN WU PHONE NO : 86 575 8867600 830 NO. 599 WUXIE ROAD, SHAOXING HIGHSE DECISION MADE: 03-MAR-16 SHAOXING CN 312000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Clean & More 3M DEUTSCHLAND GMBH 510(k) NO: K151748(Traditional) ATTN: DESI W SOEGIARTO PHONE NO : 49 8152 7001169 ESPE PLATZ SE DECISION MADE: 11-MAR-16 SEEFELD DE 82234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) Siemens Medical Solutions USA, Inc510(k) NO: K151749(Traditional) ATTN: Eve Davis PHONE NO : 610 2197133 51 Valley Stream Parkway SE DECISION MADE: 18-MAR-16 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Glide-On Vinyl Examination Gloves MEDLINE INDUSTRIES, INC. 510(k) NO: K151754(Traditional) ATTN: Jennifer Mason PHONE NO : 847 6433652 ONE MEDLINE PLACE SE DECISION MADE: 22-MAR-16 MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PerioLase Nd:YAG Pulsed Dental Laser System MILLENNIUM DENTAL TECHNOLOGIES, IN510(k) NO: K151763(Traditional) ATTN: DAVID M HARRIS PHONE NO : 562 8602908 10945 SOUTH ST., SUITE 104-A SE DECISION MADE: 15-MAR-16 CERRITOS CA 90703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM Perspective SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K151765(Traditional) ATTN: KIMBERLY MANGUM PHONE NO : 610 4484912 51 VALLEY STREAM PARKWAY SE DECISION MADE: 25-MAR-16 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating CARDINAL HEALTH 200, INC. 510(k) NO: K151778(Traditional) ATTN: CAROLINE MICELI PHONE NO : 847 8876864 1500 WAUKEGAN ROAD SE DECISION MADE: 24-MAR-16 Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAAS Workstation PIE MEDICAL IMAGING B.V. 510(k) NO: K151780(Traditional) ATTN: FLORIE DANIELS PHONE NO : 31 43 3281328 PHILIPSWEG 1 SE DECISION MADE: 11-MAR-16 MAASTRICHT NL 6227 AJ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCATOR F-Tx Attachment System ZEST ANCHORS, LLC 510(k) NO: K151789(Traditional) ATTN: ANNIE WRIGHT PHONE NO : 1 760 7437744 140 2061 WINERIDGE PLACE SE DECISION MADE: 04-MAR-16 ESCONDIDO CA 92029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 PHADIA AB 510(k) NO: K151799(Traditional) ATTN: CARINA MAGNUSSON PHONE NO : 46 18 165000 RAPSGATAN 7P SE DECISION MADE: 25-MAR-16 UPPSALA SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVATECH TALCAIR NOVATECH S.A. 510(k) NO: K151832(Traditional) ATTN: JENNIFER NEFF PHONE NO : 33 0 422981563 Z.I. ATHELIA III - 1058, VOIE ANTISE DECISION MADE: 31-MAR-16 LA CIOTAT CEDEX FR 13705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) COOPERSURGICAL, INC. 510(k) NO: K151845(Traditional) ATTN: ROAIDA JOHNSON PHONE NO : 203 6015200 95 CORPORATE DR. SE DECISION MADE: 18-MAR-16 TRUMBULL CT 06611 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens SMART PERFORMER CORP. LTD. 510(k) NO: K151847(Traditional) ATTN: JEFFERSION SHEN PHONE NO : 886 2 22999699 NO.13-1, WUQUAN 1ST RD., XINZHUANGSE DECISION MADE: 04-MAR-16 NEW TAIPEI CITY TW 242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-Fix Line Additions VILEX IN TENNESSEE, INC 510(k) NO: K151881(Traditional) ATTN: SYLVIA SOUTHARD PHONE NO : 931 4747550 111 MOFFITT STREET SE DECISION MADE: 24-MAR-16 MCMINNVILLE TN 37110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3400E series; E5400 series; E6400 series; Sundazzler series HEARTLAND TANNING, INC. 510(k) NO: K151905(Traditional) ATTN: Jon Marcum PHONE NO : 816 7951414 4251 NE Port Dr. SE DECISION MADE: 01-MAR-16 Lees Summit MO 64064 510(k) STATEMENT DEVICE: VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) BIOMERIEUX, INC. 510(k) NO: K151923(Traditional) ATTN: Cherece L Jones PHONE NO : 314 7318684 595 Anglum Road SE DECISION MADE: 25-MAR-16 Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing STRYKER CORPORATION 510(k) NO: K151932(Traditional) ATTN: SOMI EKWEALOR PHONE NO : 408 7542356 5900 OPTICAL CT SE DECISION MADE: 31-MAR-16 SAN JOSE CA 95138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Thora-3Di, Model T-01 PneumaCare LIMITED 510(k) NO: K151940(Traditional) ATTN: MARK HARWOOD PHONE NO : 44 01223 703151 ST. JOHNS INNOVATION CENTRE, COWLESE DECISION MADE: 10-MAR-16 CAMBRIDGE GB CB4 0WS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vas-Q-Clip NANOVA BIOMATERIALS INC 510(k) NO: K151943(Traditional) ATTN: ANDREW RITTS PHONE NO : 573 8233114 3806 MOJAVE CT SE DECISION MADE: 25-MAR-16 COLUMBIA MO 65202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dentti System Martz, Inc 510(k) NO: K151965(Traditional) ATTN: Andrew Martz PHONE NO : 661 3048575 8421 Blue Heron Drive SE DECISION MADE: 11-MAR-16 Bakersfield CA 93312 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Thommen Milling Abutment for CAD/CAM THOMMEN MEDICAL AG 510(k) NO: K151984(Traditional) ATTN: DANIEL SNETIVY PHONE NO : 41 61 9659020 NECKARSULMSTRASSE 28 SE DECISION MADE: 10-MAR-16 GRENCHEN CH 2540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) HARTALEGA NGC SDN BHD 510(k) NO: K151997(Traditional) ATTN: Kuan Mun Leong PHONE NO : 60 362 771733 NO. 1, PERSIARAN TANJUNG, LOT PT43SE DECISION MADE: 31-MAR-16 SEPANG MY 64000 510(k) STATEMENT DEVICE: Pure Tilt Proactive Comfort, LLC 510(k) NO: K152021(Traditional) ATTN: Tracy Augustine PHONE NO : 703 9957104 3901 Centerview Drive, Suite L SE DECISION MADE: 31-MAR-16 Chantilly VA 20151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pencylcap B. BRAUN MELSUNGEN AG 510(k) NO: K152050(Traditional) ATTN: HANS-ULRICH GAUDIN PHONE NO : 49 5661 713712 CARL-BRAUN STRASSE 1 SE DECISION MADE: 02-MAR-16 MELSUNGEN DE 34212 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ClearMet Mycone Dental Supply Co., t/a Keys510(k) NO: K152051(Traditional) ATTN: Tracey Schwear PHONE NO : 717 3763030 t/a Keystone Industries, Mizzy & DSE DECISION MADE: 22-MAR-16 Myerstown PA 17067 510(k) STATEMENT DEVICE: IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K152061(Traditional) ATTN: SUSAN BROCCHI PHONE NO : 914 5242525 511 BENEDICT AVENUE SE DECISION MADE: 03-MAR-16 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reprocessed Steerable Introducer STERILMED, INC. 510(k) NO: K152090(Traditional) ATTN: Patricia Kaufman PHONE NO : 763 4883211 5010 Cheshire Parkway N, Suite 2 SE DECISION MADE: 23-MAR-16 Plymouth MN 55446 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NobelZygoma 45° NOBEL BIOCARE AB 510(k) NO: K152093(Traditional) ATTN: JI EUN HWANG PHONE NO : 714 7824800 5030 BOX 5190, SE-402 26, VASTRA HAMNGASE DECISION MADE: 16-MAR-16 GOTEBORG SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set ROCKET MEDICAL PLC 510(k) NO: K152105(Traditional) ATTN: TRACY CHARLTON PHONE NO : 0044 191 4194488 222 2-4 SEDLING RD, WEAR INDUSTRIAL ESSE DECISION MADE: 29-MAR-16 WASHINGTON GB NE38 9BZ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: StimQ Peripheral Nerve Stimulator (PNS) System STIMQ LLC 510(k) NO: K152178(Traditional) ATTN: ELIZABETH GREENE PHONE NO : 786 4757228 901 EAST LAS OLAS BOULEVARD, SUITESE DECISION MADE: 11-MAR-16 FORT LAURDERDALE FL 33301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RejuvatoneMD TROPHY SKIN, INC. 510(k) NO: K152199(Traditional) ATTN: IMRAN KARIM PHONE NO : 469 2331768 4372 KENMARE TRAIL SE DECISION MADE: 23-MAR-16 FRISCO TX 75034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SurgTech Interbody System SURGTECH INC 510(k) NO: K152200(Traditional) ATTN: XUEGONG YU PHONE NO : 216 4212613 24600 CENTER RIDGE ROAD, SUITE 195SE DECISION MADE: 25-MAR-16 WESTLAKE OH 44145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SurgiPure XD Reconstructive Tissue Matrix TISSUE REGENIX GROUP PLC 510(k) NO: K152206(Traditional) ATTN: MIKE IZON PHONE NO : 011 440 7590048062 THE BIOCENTRE, INNOVATION WAY, HESSE DECISION MADE: 08-MAR-16 YORK GB YO20 5NY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Exactech Vantage Total Ankle System EXACTECH INC 510(k) NO: K152217(Traditional) ATTN: SHING JEN TAI PHONE NO : 352 3274368 2320 NW 66TH COURT SE DECISION MADE: 10-MAR-16 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5 SUN CAPSULE, INC. 510(k) NO: K152238(Traditional) ATTN: THOMAS P. HOLLAND PHONE NO : 800 2728267 200 1600 OSGOOD STREET, SUITE 2006 NORSE DECISION MADE: 04-MAR-16 ANDOVER MA 01845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI Corsair Armet ASAHI INTECC CO., LTD. 510(k) NO: K152249(Traditional) ATTN: YOSHIHIKO FUKUI PHONE NO : 81 52 7681211 1703 WAKITA-CHO, MORIYAMA-KU SE DECISION MADE: 04-MAR-16 NAGOYA JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Biomet Microfixation RibFix Blu Thoracic Fixation System BIOMET MICROFIXATION 510(k) NO: K152253(Traditional) ATTN: LAUREN JASPER PHONE NO : 904 7419259 1520 TRADEPORT DRIVE SE DECISION MADE: 24-MAR-16 JACKSONVILLE FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T3 Software ETIOMETRY, INC. 510(k) NO: K152258(Traditional) ATTN: DIMITAR BARONOV PHONE NO : 857 3669333 119 BRAINTREE STREET SUITE 210 SE DECISION MADE: 31-MAR-16 BOSTON MA 02134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ventix Knotless Anchors BIOMET MANUFACTURING CORP. 510(k) NO: K152262(Traditional) ATTN: JARED COOPER PHONE NO : 574 3721941 56 EAST BELL DR. SE DECISION MADE: 08-MAR-16 WARSAW IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MSCB-001 GC AMERICA INC. 510(k) NO: K152274(Traditional) ATTN: MARK HEISS PHONE NO : 708 9263090 3737 W. 127TH STREET SE DECISION MADE: 25-MAR-16 ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BioPhotas Celluma3 BIOPHOTAS, INC 510(k) NO: K152280(Traditional) ATTN: PATRICK JOHNSON PHONE NO : 714 8381956 250 EL CAMINO REAL, #110 SE DECISION MADE: 02-MAR-16 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sungshim Insulin Pen Needle SUNGSHIM MEDICARE CO., LTD. 510(k) NO: K152334(Traditional) ATTN: KIM YOUNG KWAN PHONE NO : 82 32 6767066 190, MAESIL-RO, SOJEONG-MYEON SE DECISION MADE: 17-MAR-16 SEJONG-SI KR 30002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: cryoFORM cryoICE cryoablation probe ATRICURE, INC 510(k) NO: K152337(Third Party - Traditional) ATTN: JONATHAN MCELWEE PHONE NO : 513 7554100 6217 CENTRE PARK DR SE DECISION MADE: 22-MAR-16 WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Rapicide PA High-Level Disinfectant Test Strips MEDIVATORS INC. 510(k) NO: K152394(Traditional) ATTN: MEGAN DICKEY PHONE NO : 763 5533300 14605 28TH AVE NORTH SE DECISION MADE: 11-MAR-16 MINNEAPOLIS MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) SECURUS,INC 510(k) NO: K152402(Traditional) ATTN: William J Gorman PHONE NO : 978 3170836 100 Cummings Center Suite 215F SE DECISION MADE: 04-MAR-16 Beverly MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IS4000 Stapler 30 Instrument and Stapler 30 Reloads INTUITIVE SURGICAL, INC. 510(k) NO: K152421(Traditional) ATTN: MANISH PATEL PHONE NO : 408 5232185 1266 KIFER ROAD SE DECISION MADE: 04-MAR-16 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SensiCare PI Surgical Gloves MEDLINE INDUSTRIES, INC. 510(k) NO: K152428(Traditional) ATTN: JENNIFER MASON PHONE NO : 847 6433652 ONE MEDLINE PLACE SE DECISION MADE: 31-MAR-16 MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: da Vinci Single-Site Instrument and Accessories INTUITIVE SURGICAL, INC. 510(k) NO: K152448(Traditional) ATTN: Melissa Gonzalez PHONE NO : 408 5232100 1266 KIFER ROAD SE DECISION MADE: 09-MAR-16 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Great Basin Staph ID/R Blood Culture Panel GREAT BASIN SCIENTIFIC, INC. 510(k) NO: K152470(Traditional) ATTN: Chuck Owen PHONE NO : 801 9901055 2441 S. 3850 West SE DECISION MADE: 25-MAR-16 Salt Lake City UT 84120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Revitive Medic; Revitive MV; Revitive LV Actegy, Ltd. 510(k) NO: K152480(Traditional) ATTN: Angela Glover PHONE NO : 44 013 44636940 Reflex, Cain Road SE DECISION MADE: 31-MAR-16 Bracknell GB RG12 1HL 510(k) STATEMENT DEVICE: Propeller Sensor Model 2014-R RECIPROCAL LABS 510(k) NO: K152482(Traditional) ATTN: DAVID HUBANKS PHONE NO : 608 2510470 634 W. MAIN STREET, SUITE 102 SE DECISION MADE: 04-MAR-16 MADISON WI 53703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Examination Gloves, Powder Free, (White) SHANDONG FEIYANG PROFESSIONAL GLOV510(k) NO: K152517(Traditional) ATTN: KEN LU PHONE NO : 86 13 355336830 338 HUAQING DRIVE, QIXIN CHEMICAL SE DECISION MADE: 18-MAR-16 QINZHOU CN 255400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UCP Stem UNITED ORTHOPEDIC CORPORATION 510(k) NO: K152530(Traditional) ATTN: KAREN HO PHONE NO : 886 3 5773351 2212 NO 57, PARK AVE 2, SCIENCE PARK SE DECISION MADE: 14-MAR-16 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DNAP Electrode Ad-Tech Medical Instrument Corpora510(k) NO: K152547(Traditional) ATTN: Lisa Theama PHONE NO : 262 6341555 1901 William Street SE DECISION MADE: 04-MAR-16 Racine WI 53404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Leksell Stereotactic System, Injection/ Aspiration Needle Kit ELEKTA INSTRUMENT AB 510(k) NO: K152558(Special) ATTN: EMMA WIDMARK PHONE NO : 46 8 58725400 KUNGSTENSGATAN 18, P.O. BOX 7593 SE DECISION MADE: 02-MAR-16 STOCKHOLM SE SE-103 93 510(k) STATEMENT DEVICE: da Vinci Surgical System, Model IS4000 INTUITIVE SURGICAL, INC. 510(k) NO: K152578(Traditional) ATTN: Brandon Hansen PHONE NO : 408 5232100 1266 KIFER ROAD SE DECISION MADE: 30-MAR-16 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Endo Keeper NELIS 510(k) NO: K152598(Traditional) ATTN: SEO OU NAM PHONE NO : 82 32 6241697 1005,201-DOUG BUCHEON TECHNO PARL SE DECISION MADE: 17-MAR-16 BUCHEON KR 421-742 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Olea Sphere V3.0 OLEA MEDICAL 510(k) NO: K152602(Traditional) ATTN: CAROLINE LENE PHONE NO : 011 334 42712420 93 AVENUE DES SORBIERS, ZONE ATHELSE DECISION MADE: 03-MAR-16 LA CIOTAT FR 13600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xpert Carba-R CEPHEID 510(k) NO: K152614(Traditional) ATTN: SCOTT A. CAMPBELL PHONE NO : 847 2283299 904 CARIBBEAN DRIVE SE DECISION MADE: 07-MAR-16 SUNNYVALE CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MMS Guide Catheter MicroMedical Solutions, Inc. 510(k) NO: K152625(Traditional) ATTN: Gregory Mathison PHONE NO : 218 3871559 790 Willard Street #209 SE DECISION MADE: 09-MAR-16 Quincy MA 02169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MPO Total Knee Systems MR Labeling MICROPORT ORTHOPEDICS, INC. 510(k) NO: K152631(Traditional) ATTN: USMAN RASHID PHONE NO : 901 2905274 5677 AIRLINE ROAD SE DECISION MADE: 23-MAR-16 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) FUDAKANG INDUSTRIES CO., LTD 510(k) NO: K152640(Special) ATTN: BOB YU PHONE NO : 86 769 81098181 NO.8 YINGHE ROAD, YUANJIANGYUAN MSE DECISION MADE: 28-MAR-16 DONGGUAN CN 523560 510(k) STATEMENT DEVICE: SYLK PERSONAL LUBRICANT TORO MANAGEMENT LLC DBA SYLK 510(k) NO: K152646(Traditional) ATTN: MARIESSA MAHFOUZ PHONE NO : 480 2075270 7272 EAST INDIAN SCHOOL ROAD SUITESE DECISION MADE: 11-MAR-16 SCOTTSDALE AZ 85251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-Wire Spinal Resources Inc 510(k) NO: K152662(Traditional) ATTN: Bernard Bedor PHONE NO : 904 5409049 274 E Eau Gallie Blvd Unit 303 SE DECISION MADE: 09-MAR-16 Indian Harbour Beach FL 32937 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: iFuse Implant System(R) SI-BONE, INC. 510(k) NO: K152681(Traditional) ATTN: ROXANNE DUBOIS PHONE NO : 408 2070700 2236 3055 OLIN AVENUE, SUITE 2200 SE DECISION MADE: 01-MAR-16 SAN JOSE CA 95128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONQUEST FN Smith & Nephew 510(k) NO: K152686(Traditional) ATTN: Bradley Heil PHONE NO : 901 3996339 1450 E. Brooks Rd. SE DECISION MADE: 17-MAR-16 Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Apollo System PENUMBRA, INC. 510(k) NO: K152699(Traditional) ATTN: MARY ROSE PHONE NO : 510 7483346 ONE PENUMBRA PLACE SE DECISION MADE: 17-MAR-16 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color Jiayuan Medical Products Co., Ltd 510(k) NO: K152705(Traditional) ATTN: Wang Lihong PHONE NO : 86 315 4160678 Xihuan Road, Luannan County SE DECISION MADE: 17-MAR-16 Tangshan CN 063500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color MINGHAO MEDICAL PRODUCTS CO.,LTD. 510(k) NO: K152707(Traditional) ATTN: PANG CUIRU PHONE NO : 86 315 8230716 WEST INDUSTRIAL PARK, LUANNAN COUNSE DECISION MADE: 17-MAR-16 TANGSHAN CN 063500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Powder Free Patient Examination Gloves, Blue Color Zhonghong Pulin Medical Products C510(k) NO: K152712(Traditional) ATTN: LI Jinge PHONE NO : 86 315 4165760 Pachigang Industrial Park, LuannanSE DECISION MADE: 09-MAR-16 Tangshan CN 063502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EV Insite System PSP Corporation 510(k) NO: K152716(Traditional) ATTN: Kenji Ishida PHONE NO : 03 5485 1028 Nishi-azabu 28 Moribldg. Nishi-azaSE DECISION MADE: 24-MAR-16 Minato-ku Tokyo JP 106-0031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves XINFU MEDICAL PRODUCTS CO., LTD. 510(k) NO: K152719(Traditional) ATTN: XIE WENXING PHONE NO : 86 315 4431166 EAST OF LIPINGTUO, LUANNAN COUNTY SE DECISION MADE: 01-MAR-16 TANGSHAN CITY CN 063502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color XINGDA MEDICAL PRODUCTS CO., LTD. 510(k) NO: K152720(Traditional) ATTN: ZHANG LIXIA PHONE NO : 86 315 4160290 SOUTH OF SHENGZHUANG VILLAGE, LUANSE DECISION MADE: 10-MAR-16 TANGSHAN CN 063502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Braun Thermoscan PRO 6000 Ear Thermometer KAZ USA, INC (A SUBSIDIARY OF HELE510(k) NO: K152748(Traditional) ATTN: RAJ KASBEKAR PHONE NO : 508 4907280 250 TURNPIKE ROAD SE DECISION MADE: 01-MAR-16 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CharmFlex DENTKIST, INC 510(k) NO: K152766(Traditional) ATTN: SHIN HEANG LEE PHONE NO : 82 31 4582822 (DANGJEONG-DONG) 3, NONGSIM-RO SE DECISION MADE: 08-MAR-16 GUNPO-SI KR 15842 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U&U Insulin Syringe with/without Safety Retractable Device U&U Medical Technology Co., Ltd 510(k) NO: K152808(Traditional) ATTN: Black Wang PHONE NO : 0086 139 02471751 Dongzhou Village, Hengshanqiao SE DECISION MADE: 25-MAR-16 Changzhou CN 213119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Giraffe OmniBed Carestation CS1 Ohmeda Medical, a Division of Date510(k) NO: K152814(Special) ATTN: Kenny M Bello PHONE NO : 410 8885393 8880 Gorman Rooad SE DECISION MADE: 17-MAR-16 Laurel MD 20723 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mailuokang Self-adhesive Electrode SHENZHEN MAILUOKANG TECHNOLOGY CO.510(k) NO: K152815(Traditional) ATTN: HU PANDENG PHONE NO : 86 755 85258460 RM 602, 6/F, BUILDING B, NANCHANG SE DECISION MADE: 08-MAR-16 SHENZHEN CN 518000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDT PEN NEEDLE SHANDONG CAREMED MEDICAL PRODUCTS 510(k) NO: K152824(Traditional) ATTN: LIN YANYAN PHONE NO : 86 530 7397700 (YANTAI) INDUSTRIAL PARK DING TAO SE DECISION MADE: 07-MAR-16 HEZE CN 274100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URITEK TC-201 URINE CHEMISTRY TEST SYSTEM TECO DIAGNOSTICS, INC. 510(k) NO: K152835(Traditional) ATTN: YUNYUAN VIVIAN WANG PHONE NO : 714 4631111 1268 N. LAKEVIEW AVE. SE DECISION MADE: 07-MAR-16 ANAHEIM CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Allied Biocompat Abutment for Nobel Replace Interface ALLIED DENTAL SOLUTIONS 510(k) NO: K152845(Traditional) ATTN: Peter Zhou PHONE NO : 909 5988036 1170 CENTRE DR #1 SE DECISION MADE: 14-MAR-16 CITY OF INDUSTRY CA 91789 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aquasil Ultra + Smart Wetting Impression Material DENTPLY INTERNATIONAL INC. 510(k) NO: K152861(Special) ATTN: HELEN LEWIS PHONE NO : 717 4871332 221 WEST PHILADELPHIA STREET, SUITSE DECISION MADE: 04-MAR-16 YORK PA 17405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Propeller System RECIPROCAL LABS 510(k) NO: K152882(Traditional) ATTN: DAVID HUBANKS PHONE NO : 1 608 2510470 634 W. MAIN STREET, SUITE 102 SE DECISION MADE: 08-MAR-16 MADISON WI 53703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K152897(Traditional) ATTN: JENNIFER SIEGEL PHONE NO : 1 609 2750500 311 ENTERPRISE DRIVE SE DECISION MADE: 04-MAR-16 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNI Skirted Heads OMNILIFE SCIENCE INC. 510(k) NO: K152919(Traditional) ATTN: Vani Sindwani PHONE NO : 508 8242444 50 O'CONNELL WAY SUITE 10 SE DECISION MADE: 10-MAR-16 EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vesalius TELEA ELECTRONIC ENGINEERING SRL 510(k) NO: K152933(Special) ATTN: Simona Daidone PHONE NO : 39 0444 239519 VIA LEONARDO DA VINCI 13 SE DECISION MADE: 23-MAR-16 SANDRIGO IT 36066 510(k) STATEMENT DEVICE: LiDCOunity Monitor LIDCO LTD 510(k) NO: K152935(Traditional) ATTN: ERIC MILLS PHONE NO : 44 20 77491500 16 ORSMAN ROAD SE DECISION MADE: 17-MAR-16 LONDON GB N1 5QJ 510(k) STATEMENT DEVICE: DBB-06 Hemodialysis Delivery System NIKKISO, CO.,LTD. 510(k) NO: K152938(Traditional) ATTN: SEIYA RAIJYU PHONE NO : 81 3 34433754 20-3, EBISU 4-CHOME SE DECISION MADE: 18-MAR-16 SHIBUYA-KU JP 150-6022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Great Basin Shiga Toxin Direct Test GREAT BASIN SCIENTIFIC, INC. 510(k) NO: K152955(Traditional) ATTN: Chuck Owen PHONE NO : 801 9901055 2441 S. 3850 West SE DECISION MADE: 22-MAR-16 Salt Lake City UT 84120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MultiCross Catheter ROXWOOD MEDICAL, INC. 510(k) NO: K152957(Special) ATTN: Grace Li PHONE NO : 650 7794559 400 SEAPORT CT, SUITE #103 SE DECISION MADE: 04-MAR-16 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY CONMED CORPORATION 510(k) NO: K152969(Traditional) ATTN: DIONNE SANDERS PHONE NO : 727 3995564 525 FRENCH ROAD SE DECISION MADE: 31-MAR-16 UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VDT985US Vicks SmartTemp Thermometer Kaz USA, Inc., a Helen of Troy Com510(k) NO: K152975(Traditional) ATTN: Raj Kasbekar PHONE NO : 508 4907280 250 Turnpike Road SE DECISION MADE: 23-MAR-16 Southborough MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DeRoyal Angiography Kits DEROYAL INDUSTRIES, INC. 510(k) NO: K152978(Traditional) ATTN: Elizabeth Wheeler PHONE NO : 865 3622333 200 DEBUSK LANE SE DECISION MADE: 25-MAR-16 POWELL TN 37849 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CorPath 200 System CORINDUS, INC. 510(k) NO: K152999(Traditional) ATTN: Tal Wenderow PHONE NO : 508 6533335 309 Waverley Oaks Road Suite 105 SE DECISION MADE: 18-MAR-16 Waltham MA 02452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes BIO ROTECH, INC. 510(k) NO: K153019(Traditional) ATTN: DANIEL WOO PHONE NO : 82 33 7357720 DONGHWA MEDICAL INSTRUMENT COMPLEXSE DECISION MADE: 21-MAR-16 WONJU-SI KR 220-801 510(k) STATEMENT DEVICE: Cryotop US KITAZATO BIOPHARMA CO., LTD. 510(k) NO: K153027(Traditional) ATTN: FUTOSHI INOUE PHONE NO : 81 545 662202 81 Nakajima SE DECISION MADE: 14-MAR-16 FUJI JP 416-0907 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K153041(Traditional) ATTN: Timothy Connors PHONE NO : 609 9365531 311 Enterprise Drive SE DECISION MADE: 14-MAR-16 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRYPTIK2C-plate Anterior Cervical Plate System SPINEART 510(k) NO: K153042(Traditional) ATTN: Franck PENNESI PHONE NO : 41 225 701246 INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 28-MAR-16 GENEVA CH 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sentimag System, Sentimark Magnetic Marker Systerm ENDOMAGNETICS LTD. 510(k) NO: K153044(Traditional) ATTN: ANDREW SHAWCROSS PHONE NO : 44 0 1223652540 THE JEFFREYS BUILDING, COWLEY ROADSE DECISION MADE: 02-MAR-16 CAMBRIDGE GB CB4 OWS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Axeo 3 Patient Monitor AXEO MEDICAL TECHNOLOGIES, LLC 510(k) NO: K153079(Traditional) ATTN: Stamatios Parimeros PHONE NO : 727 7872936 971 VIRGINIA AVENUE SUITE A SE DECISION MADE: 17-MAR-16 PALM HARBOR FL 34683 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reprocessed Diagnostic Ultrasound Catheter INNOVATIVE HEALTH, LLC 510(k) NO: K153090(Traditional) ATTN: RAFAL CHUDZIK PHONE NO : 480 5256006 1435 NORTH HAYDEN ROAD, SUITE 100 SE DECISION MADE: 10-MAR-16 SCOTTSDALE AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, SUMMIT INDUSTRIES LLC 510(k) NO: K153119(Traditional) ATTN: Tom Boon PHONE NO : 773 3534024 2901 W LAWRENCE AVE SE DECISION MADE: 14-MAR-16 Chicago IL 60625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Infrared Ear Thermometer SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K153146(Traditional) ATTN: REN YUNHUA PHONE NO : 86 571 81957767 BUILDING 2, NO. 202, ZHENZHONG ROASE DECISION MADE: 31-MAR-16 HANGZHOU CN 310030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reprocessed Electrophysiology Catheter INNOVATIVE HEALTH, LLC 510(k) NO: K153153(Traditional) ATTN: RAFAL CHUDZIK PHONE NO : 480 5256006 1435 NORTH HAYDEN ROAD, SUITE 100 SE DECISION MADE: 14-MAR-16 SCOTTSDALE AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVIVO Mobile Patient Management (MPM) System MEDTRONIC, INC. 510(k) NO: K153160(Special) ATTN: CHERYL L. SWANSON PHONE NO : 763 5140088 8200 CORAL SEA STREET NE SE DECISION MADE: 30-MAR-16 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: iMESH Tacker THD LAP 510(k) NO: K153202(Special) ATTN: Einat Duvdevany PHONE NO : 972 52 6717051 1 NIRIM ST. SE DECISION MADE: 24-MAR-16 TEL AVIV IL 6706036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K153206(Traditional) ATTN: Shraddha More PHONE NO : 973 6862627 522627 10 HIGH POINT DRIVE SE DECISION MADE: 03-MAR-16 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sheathes Ultrasound Probe Covers Sheathing Technologies, Inc. 510(k) NO: K153212(Traditional) ATTN: JENNIFER DOWNING PHONE NO : 408 7822720 12 18431 TECHNOLOGY DRIVE SE DECISION MADE: 04-MAR-16 MORGAN HILL CA 95037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit ZOLL CIRCULATION, INC. 510(k) NO: K153226(Traditional) ATTN: SAM NANAVATI PHONE NO : 408 4192950 2000 RINGWOOD AVE. SE DECISION MADE: 24-MAR-16 SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OrthAlign Plus System OrthAlign, Inc. 510(k) NO: K153237(Traditional) ATTN: David Vancelette PHONE NO : 949 7152424 120 Columbia, Suite 500 SE DECISION MADE: 01-MAR-16 Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dignity Dual Port Medcomp ( Medical Components) 510(k) NO: K153238(Traditional) ATTN: Beth Ann Giammaruti PHONE NO : 215 2564201 1499 Delp Drive SE DECISION MADE: 15-MAR-16 Harleysville PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cios Fusion SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K153244(Traditional) ATTN: DARREN A. DORMAN PHONE NO : 610 4486483 40 LIBERTY BOULEVARD 65-1A SE DECISION MADE: 07-MAR-16 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Baha 5 Super Power Sound Processor COCHLEAR AMERICAS 510(k) NO: K153245(Traditional) ATTN: TRISTAN MANUS PHONE NO : 303 7909010 13059 E. PEAKVIEW AVE SE DECISION MADE: 02-MAR-16 CENTENNIAL CO 80111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEEK Customized Cranial Implant STRYKER 510(k) NO: K153248(Traditional) ATTN: Jonathan Schell PHONE NO : 269 3895596 750 TRADE CENTRE WAY SUITE 200 SE DECISION MADE: 10-MAR-16 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System RENOVIS SURGICAL TECHNOLOGIES 510(k) NO: K153250(Traditional) ATTN: ANTHONY DEBENEDICTIS PHONE NO : 909 5572360 1901 W. LUGONIA SE DECISION MADE: 16-MAR-16 REDLANDS CA 92374 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GC Reline II GC AMERICA, INC. 510(k) NO: K153253(Traditional) ATTN: MARK HEISS PHONE NO : 708 9263090 3737 W. 127TH ST. SE DECISION MADE: 03-MAR-16 ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TruGuard Custom Tongue and Jaw Positioner BIONIX DEVELOPMENT CORP. 510(k) NO: K153270(Traditional) ATTN: JAMES HUTTNER PHONE NO : 419 7278421 5154 ENTERPRISE BLVD. SE DECISION MADE: 08-MAR-16 TOLEDO OH 43612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BrightMatter Guide with Surface Trace Registration SYNAPTIVE MEDICAL INC. 510(k) NO: K153281(Traditional) ATTN: Cameron Piron PHONE NO : 416 6736679 MARS CENTER, SOUTH TOWER, 101 COLLSE DECISION MADE: 30-MAR-16 TORONTO CA M5G1L7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Synaptive ImageDrive Pro SYNAPTIVE MEDICAL INC. 510(k) NO: K153284(Traditional) ATTN: Cameron Piron PHONE NO : 41 667 36679 MARS CENTER, SOUTH TOWER, 101 COLLSE DECISION MADE: 29-MAR-16 TORONTO CA M5G1L7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SICAT OPTISLEEP SICAT GMBH & CO. KG 510(k) NO: K153291(Abbreviated) ATTN: MANFRED BREUER PHONE NO : 49 228 85469782 BRUNNENALLEE 6 SE DECISION MADE: 31-MAR-16 BONN DE 53177 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tenex Health TX System TENEX HEALTH, INC. 510(k) NO: K153299(Traditional) ATTN: GLORIA PENDERGRASS PHONE NO : 949 4547500 26902 VISTA TERRACE SE DECISION MADE: 03-MAR-16 LAKE FOREST CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ingenia 1.5T and Ingenia 1.5T S R5.2 PHILIPS MEDICAL SYSTEMS, NEDERLAND510(k) NO: K153324(Abbreviated) ATTN: Henrie Daniels PHONE NO : 31 402 762192 VEENPLUIS 4-6 SE DECISION MADE: 22-MAR-16 BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Erisma-LP Spinal Fixation System CLARIANCE, SAS 510(k) NO: K153326(Special) ATTN: PASCAL ROKEGEM PHONE NO : 33 321 161215 18, rue Robespierre SE DECISION MADE: 08-MAR-16 BEAURAINS FR 62217 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AlertWatch: OR ALERTWATCH LLC 510(k) NO: K153335(Traditional) ATTN: Justin Adams PHONE NO : 734 9988344 1600 HURON PARKWAY, BLDG. 520, STESE DECISION MADE: 15-MAR-16 ANN ARBOR MI 48109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Corvocet Biopsy System MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K153337(Traditional) ATTN: Ileana Davis PHONE NO : 801 2084187 1600 WEST MERIT PARKWAY SE DECISION MADE: 25-MAR-16 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: syngo Application Software VD11 Siemens Medical Solutions USA, Inc510(k) NO: K153346(Traditional) ATTN: Patricia D Jones PHONE NO : 610 4486474 40 Liberty Boulevard 65-1A SE DECISION MADE: 04-MAR-16 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JAZZ LOCK Implanet, S.A. 510(k) NO: K153348(Traditional) ATTN: Regis Le Couedic PHONE NO : 33 557 995555 Technopole Bordeaux Montesquieu AlSE DECISION MADE: 31-MAR-16 Martillac FR 33650 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xeleris 4.0 Processing and Review Workstation GE HEALTHCARE 510(k) NO: K153355(Traditional) ATTN: EFRAT HARTOG-DAVID PHONE NO : 972 4 8563666 4 HAYOZMA STREET SE DECISION MADE: 16-MAR-16 TIRAT HACARMEL IL 30200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sonicision Cordless Ultrasonic Dissection Device COVIDIEN LLC 510(k) NO: K153371(Traditional) ATTN: NANCY SAUER PHONE NO : 1 303 5816791 5920 LONGBOW DRIVE SE DECISION MADE: 28-MAR-16 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) IN LIGHT WELLNESS SYSTEMS, INC. 510(k) NO: K153389(Traditional) ATTN: JANE MELONE PHONE NO : 1 505 4047130 5601 MIDWAY PARK PLACE NE SE DECISION MADE: 30-MAR-16 ALBUQUERQUE NM 87109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERIZONE VP4 Sterilizer TS03 INC 510(k) NO: K153392(Traditional) ATTN: Nathalie Racette PHONE NO : 418 6510003 294 2505, AVENUE DALTON SE DECISION MADE: 24-MAR-16 QUEBEC CA G1P 3S5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ProLift Expandable System LIFE SPINE, INC. 510(k) NO: K153400(Traditional) ATTN: RANDY LEWIS PHONE NO : 847 8846117 13951 S QUALITY DRIVE SE DECISION MADE: 07-MAR-16 HUNTLEY IL 60142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sleep Profiler ADVANCED BRAIN MONITORING, INC. 510(k) NO: K153412(Traditional) ATTN: DANIEL J. LEVENDOWSKI PHONE NO : 760 7200099 6040 2237 FARADAY AVENUE SUITE 100 SE DECISION MADE: 14-MAR-16 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SmartView 3D Option GE HANGWEI MEDICAL SYSTEM CO., LTD510(k) NO: K153429(Traditional) ATTN: LV RUI PHONE NO : 86 10 58068888 71063 NO.1, YONG CHANG STREET, BEIJING SE DECISION MADE: 09-MAR-16 BEIJING CN 100176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select COOK INCORPORATED 510(k) NO: K153430(Special) ATTN: SARAH REEVES PHONE NO : 812 3353575 105024 750 DANIELS WAY, P.O. BOX 489 SE DECISION MADE: 07-MAR-16 BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIMETER C (Titanium) Spinal System MEDTRONIC SOFAMOR DANEK USA, INC 510(k) NO: K153438(Special) ATTN: MICHAEL SCOTT PHONE NO : 901 3963133 1800 PYRAMID PLACE SE DECISION MADE: 02-MAR-16 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VibraPEP Medica Holdings, LLC 510(k) NO: K153441(Traditional) ATTN: George Reed PHONE NO : 503 2235360 5200 Meadows Road, Suite 150 SE DECISION MADE: 25-MAR-16 Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETOM Spectra SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K153447(Special) ATTN: CORDELL L. FIELDS PHONE NO : 610 4486469 65 VALLEY STREAM PARKWAY SE DECISION MADE: 31-MAR-16 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Passport Series Patient Monitors (Including Passport 8, Passport 12) SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K153448(Traditional) ATTN: BAI YANHONG PHONE NO : 86 755 81888998 MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 03-MAR-16 NANSHAN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) AVINGER, INC. 510(k) NO: K153460(Traditional) ATTN: Patty Hevey PHONE NO : 650 2417900 400 CHESAPEAKE DRIVE SE DECISION MADE: 01-MAR-16 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) Assure Tech (Hangzhou) Co., Ltd. 510(k) NO: K153465(Traditional) ATTN: Shisheng Ling PHONE NO : 86 571 88868960 No. 10, Xiyuansan Rd., Westlake EcSE DECISION MADE: 31-MAR-16 Hangzhou CN 310030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENROUTE Transcarotid Neuroprotection System SILK ROAD MEDICAL, INC. 510(k) NO: K153485(Traditional) ATTN: KRISTIN ELLIS PHONE NO : 408 7209002 735 NORTH PASTORIA AVENUE SE DECISION MADE: 10-MAR-16 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System LDR Spine USA 510(k) NO: K153495(Traditional) ATTN: Brad Strasser PHONE NO : 512 3443333 13785 Research Boulevard, Suite 20SE DECISION MADE: 31-MAR-16 Austin TX 78750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder Free Polychloroprene Examination Glove Green TERANG NUSA SDN BHD 510(k) NO: K153510(Traditional) ATTN: ROBERT HILL PHONE NO : 006 09 7747171 1 JALAN 8, PENGKALAN CHEPA 2 INDUSSE DECISION MADE: 21-MAR-16 KOTA BHARU MY 16100 510(k) STATEMENT DEVICE: Insufflator 50L FM134 W.O.M WORLD OF MEDICINE GMBH 510(k) NO: K153513(Traditional) ATTN: Soeren Markworth PHONE NO : 11 49 3039981594 SALZUFER 8 SE DECISION MADE: 04-MAR-16 BERLIN DE 10587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DReal CAREVATURE MEDICAL LTD 510(k) NO: K153519(Traditional) ATTN: Orly Maor PHONE NO : 972 8 6757073 42 Tvuot Haarets St. SE DECISION MADE: 16-MAR-16 Tel Aviv IL 6954648 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PicoWay Laser System SYNERON CANDELA CORPORATION 510(k) NO: K153527(Traditional) ATTN: Ruthie Amir PHONE NO : 508 3587400 330 530 BOSTON POST ROAD SE DECISION MADE: 02-MAR-16 Wayland MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON Oval V 5.1 MRI System Hitachi Medical Systems America, I510(k) NO: K153547(Special) ATTN: Doug Thistlethwaite PHONE NO : 330 4251313 1959 Summit Commerce Park SE DECISION MADE: 31-MAR-16 Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Genesis Low Temperature Reusable Rigid Container System CareFusion 2200 Inc 510(k) NO: K153554(Traditional) ATTN: Jane Weber PHONE NO : 847 3628094 75 N. Fairway Drive SE DECISION MADE: 21-MAR-16 Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURE CRYOGEN AIR LIQUIDE HEALTHCARE AMERICA COR510(k) NO: K153564(Traditional) ATTN: STEVE MILLER PHONE NO : 713 8962280 12800 WEST LITTLE YORK ROAD SE DECISION MADE: 29-MAR-16 HOUSTON TX 77041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NeoTract UroLift System UL500 NeoTract, Inc. 510(k) NO: K153584(Traditional) ATTN: Nancy E Isaac PHONE NO : 650 2692552 4473 Willow Road, Suite 100 SE DECISION MADE: 15-MAR-16 Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Optetrak Logic Metaphyseal Cones EXACTECH INC 510(k) NO: K153595(Traditional) ATTN: PATRICK HUGHES PHONE NO : 352 3274762 2320 NW 66TH COURT SE DECISION MADE: 25-MAR-16 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ArthrexVIP Web Portal CUSTOM ORTHOPAEDIC SOLUTIONS, INC.510(k) NO: K153612(Traditional) ATTN: Keith Grafmeyer PHONE NO : 216 4453403 10000 CEDAR AVENUE SE DECISION MADE: 15-MAR-16 CLEVELAND OH 44106 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cerafix Dura Substitute ACERA SURGICAL, INC. 510(k) NO: K153613(Traditional) ATTN: MATTHEW MACEWAN PHONE NO : 440 4471890 10880 BAUR BLVD. SE DECISION MADE: 16-MAR-16 ST. LOUIS MO 63132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive® TLX Interbody System NUVASIVE INCORPORATED 510(k) NO: K153627(Traditional) ATTN: CYNTHIA ADAMS PHONE NO : 858 3204549 7475 LUSK BOULEVARD SE DECISION MADE: 17-MAR-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Endoform Reconstructive Template Aroa Biosurgery Limited (Formerly 510(k) NO: K153633(Special) ATTN: Yasmin Rai PHONE NO : 64 9 8693035 2 Kingsford Smith Place, Airport OSE DECISION MADE: 15-MAR-16 Auckland NZ 2022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana SAFECARE BIOTECH (HANGZHOU)CO.,LTD510(k) NO: K153646(Traditional) ATTN: Alex Qiu PHONE NO : 86 571 89712897 BUILDING 2/203 NO.18 HAISHU RD., SE DECISION MADE: 18-MAR-16 HANGZHOU CN 311121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ImmunoCard STAT! HpSA Meridian Bioscience, Inc 510(k) NO: K153661(Traditional) ATTN: Susan Rolih PHONE NO : 513 2713700 3471 River Hills Drive SE DECISION MADE: 14-MAR-16 Cincinnati OH 45244 510(k) STATEMENT DEVICE: TRUESPAN Meniscal Repair System Medos International SARL 510(k) NO: K153667(Traditional) ATTN: Kristine Christo PHONE NO : Chemin-Blanc 38 SE DECISION MADE: 24-MAR-16 Le Locle Neuchatel CH 2400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Family of CoolGlide Aesthetic Lasers CUTERA, INC. 510(k) NO: K153671(Traditional) ATTN: Julia Brown PHONE NO : 415 6575575 3240 BAYSHORE BLVD. SE DECISION MADE: 09-MAR-16 BRISBANE CA 94005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL Liofilchem s.r.l 510(k) NO: K153687(Traditional) ATTN: Fabio Brocci PHONE NO : 39 085 8930745 64026 Roseto Degli SE DECISION MADE: 31-MAR-16 Abruzzi IT 510(k) STATEMENT DEVICE: Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators IMMUNALYSIS CORPORATION 510(k) NO: K153693(Traditional) ATTN: JOSEPH GINETE PHONE NO : 909 4820840 829 TOWNE CENTER DRIVE SE DECISION MADE: 18-MAR-16 POMONA CA 91767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Halyard Black-Orange Powder-Free Nitrile Exam Glove Halyard Health 510(k) NO: K153708(Abbreviated) ATTN: Christine L Macauley PHONE NO : 470 4485158 5405 Windward Parkway SE DECISION MADE: 31-MAR-16 Alpharetta GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tuxedo Digital Dental Sensor LED DENTAL INC 510(k) NO: K153710(Traditional) ATTN: Wesley Newsom PHONE NO : 404 4322819 NO.235-5589 BYRNE RD. SE DECISION MADE: 18-MAR-16 Burnaby CA V5J 3J1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Venus Versa System Venus Concept Ltd. 510(k) NO: K153717(Traditional) ATTN: Tal Bresler-Stramer PHONE NO : 416 9070115 4556 N. Hiatus Road SE DECISION MADE: 21-MAR-16 Sunrise FL 33351 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: iTotal Cruciate Retaining (CR) Knee Replacement System CONFORMIS, INC. 510(k) NO: K153721(Traditional) ATTN: Amita Shah PHONE NO : 781 3459164 28 Crosby Dr. SE DECISION MADE: 25-MAR-16 Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Corin TaperFit Hip Stem CORIN USA LIMITED 510(k) NO: K153725(Traditional) ATTN: DIANA L. NADER-MARTONE PHONE NO : 813 9774469 5670 W. CYPRESS ST. SUITE C SE DECISION MADE: 25-MAR-16 TAMPA FL 33607 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test HANGZHOU CLONGENE BIOTECH CO., LTD510(k) NO: K153741(Traditional) ATTN: ZHENG SHUJIAN PHONE NO : 86 571 88262120 BUILDING 4, NO.20 LONGQUAN ROAD YSE DECISION MADE: 18-MAR-16 HANGZHOU CN 311121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dunamis Force DFX Tensile Tape Dunamis LLC 510(k) NO: K153746(Traditional) ATTN: Prithvi Raj Chavan PHONE NO : 731 2172533 693 Sherling Lake Rd. Apt. 122 SE DECISION MADE: 03-MAR-16 Greenville AL 36037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MicroMatrix ACELL, INC 510(k) NO: K153754(Special) ATTN: THOMAS GILBERT PHONE NO : 410 9538509 6640 ELI WHITNEY DRIVE SE DECISION MADE: 14-MAR-16 COLUMBIA MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Straumann Bone Level Tapered Implants INSTITUT STRAUMANN AG 510(k) NO: K153758(Traditional) ATTN: Christopher Klaczyk PHONE NO : 41 61 9651260 PETER MERIAN-WEG 12 SE DECISION MADE: 23-MAR-16 BASEL CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-cera Zirconia Blanks SHENZHEN XIANGTONG PHOTOELECTRICIT510(k) NO: K153767(Third Party - Traditional) ATTN: YONGQING CHEN PHONE NO : 0086 755 86001804 2~4TH FLOOR, 1ST BUILDING, SOUTH ISE DECISION MADE: 29-MAR-16 SHENZHEN CN 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OS2(R)-VP Varisation Staple IN2BONES SAS 510(k) NO: K153770(Traditional) ATTN: MORGANE GRENIER PHONE NO : 33 47 2292626 28 CHEMIN DU PETIT BOIS SE DECISION MADE: 21-MAR-16 ECULLY FR 69130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Corin TriFit TS Hip CORIN USA LIMITED 510(k) NO: K153772(Traditional) ATTN: Diana L. Nader-Martone PHONE NO : 813 9774469 5670 W. CYPRESS ST. SUITE C SE DECISION MADE: 31-MAR-16 TAMPA FL 33607 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Optetrak One Logic Femoral Components Exactech Inc 510(k) NO: K153776(Special) ATTN: Patrick Hughes PHONE NO : 352 3274762 2320 NW 66th CT SE DECISION MADE: 10-MAR-16 Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Abutment for Bridges ALTATEC GmbH 510(k) NO: K153779(Traditional) ATTN: Colleen Boswell PHONE NO : 49 7044 94450 Maybachstrasse 5 SE DECISION MADE: 31-MAR-16 Wimsheim DE D-71299 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive® Lumbar Interbody Implants NUVASIVE, INCORPORATED 510(k) NO: K153782(Traditional) ATTN: MARTIN YAHIRO PHONE NO : 858 3206157 7475 LUSK BLVD. SE DECISION MADE: 24-MAR-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Piccolo Composite(R) Distal Volar Radius Plate System CARBOFIX ORTHOPEDICS LTD. 510(k) NO: K160002(Special) ATTN: Yael Rubin PHONE NO : 972 995 11511 11 HA'HOSHLIM STREET SE DECISION MADE: 09-MAR-16 HERZELIYA IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System Captiva Spine 510(k) NO: K160020(Special) ATTN: Tamala J. Wampler PHONE NO : 877 7725571 967 N. Alternate A1A Ste 1 SE DECISION MADE: 02-MAR-16 Jupiter FL 33477 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System CONFORMIS, INC. 510(k) NO: K160025(Special) ATTN: Amita Shah PHONE NO : 781 3459164 28 Crosby Dr. SE DECISION MADE: 07-MAR-16 Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cobbra RF Tissue Dissector ELLIQUENCE LLC. 510(k) NO: K160041(Traditional) ATTN: PAUL D. BUHRKE PHONE NO : 516 2779010 2455 Grand Avenue SE DECISION MADE: 07-MAR-16 Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Biomet Variable Pitch Compression Screw System Biomet Inc 510(k) NO: K160058(Traditional) ATTN: Julie Largent PHONE NO : 305 2696391 56 East Bell Drive SE DECISION MADE: 09-MAR-16 Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System INFOBIONIC, INC. 510(k) NO: K160064(Abbreviated) ATTN: NANCY BRIEFS PHONE NO : 978 6748304 600 SUFFOLK STREET SE DECISION MADE: 11-MAR-16 LOWELL MA 01854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sonoma Fibula Repair System Sonoma Orthopedics Products, Inc 510(k) NO: K160069(Traditional) ATTN: Rick Epstein PHONE NO : 1388 Busch Parkway SE DECISION MADE: 10-MAR-16 Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vivid T8 GE Medical Systems Ultrasound and 510(k) NO: K160078(Traditional) ATTN: Tracey Ortiz PHONE NO : 262 6766120 9900 W. Innovation Drive SE DECISION MADE: 10-MAR-16 Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System ZIMMER GMBH 510(k) NO: K160085(Special) ATTN: Roberto Tommasini PHONE NO : 41 588 548264 SULZERALLEE 8 SE DECISION MADE: 08-MAR-16 WINTERTHUR CH 8404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Single Use Aspiration Needle NA-U401SX OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K160098(Traditional) ATTN: TOSHIYUKI NAKAJIMA PHONE NO : 81 42 6422694 2951 ISHIKAWA-CHO SE DECISION MADE: 22-MAR-16 HACHIOJI-SHI JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xspan Laminoplasty Fixation System X-SPINE SYSTEMS, INC. 510(k) NO: K160114(Traditional) ATTN: Kriss Anderson PHONE NO : 937 8478400 452 ALEXANDERSVILLE RD. SE DECISION MADE: 15-MAR-16 MIAMISBURG OH 45342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D-SPECT Processing and Reviewing Workstation SPECTRUM DYNAMICS LTD. 510(k) NO: K160120(Traditional) ATTN: YORAM LEVY PHONE NO : 972 73 7374500 22 BAREKET STREET SE DECISION MADE: 21-MAR-16 CAESAREA IL 30889 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRII Cranial Drill and Accessories MRI INTERVENTIONS, INC. 510(k) NO: K160129(Special) ATTN: PETER PIFERI PHONE NO : 949 9006833 5 MUSICK SE DECISION MADE: 26-MAR-16 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co., Ltd. 510(k) NO: K160145(Traditional) ATTN: Sarah Su PHONE NO : 886 2 82271300 1201 9F, No. 186, Jian Yi Road SE DECISION MADE: 13-MAR-16 Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vitrea CT Colon Analysis Vital Images, Inc. 510(k) NO: K160150(Traditional) ATTN: Alexis Erazo PHONE NO : 952 4879774 5850 Opus Parkway, Suite 300 SE DECISION MADE: 16-MAR-16 Minnetonka MN 55343-4414 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Wrist 3 ASPECT IMAGING LTD 510(k) NO: K160185(Third Party - Traditional) ATTN: ISRAEL CITRON PHONE NO : 972 732 239000 27 SHAKED STREET SE DECISION MADE: 01-MAR-16 INDUSTRIAL AREA HEVEL MODI'IN IL 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Align Anterior Ankle Fusion Plate Extremity Medical, LLC 510(k) NO: K160191(Traditional) ATTN: Brian Smekal PHONE NO : 973 5888980 300 Interpace Parkway, Suite 410 SE DECISION MADE: 25-MAR-16 Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NILE Alternative Fixation Spinal System K2M, Inc. 510(k) NO: K160208(Special) ATTN: NANCY GIEZEN PHONE NO : 571 9192000 751 MILLER DRIVE SE SE DECISION MADE: 18-MAR-16 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUVUE (senofilcon C) Soft Contact Lens Johnson & Johnson Vision Care, Inc510(k) NO: K160212(Traditional) ATTN: Ramona Haile PHONE NO : 904 4431191 7500 Centurion Parkway, Suite 100 SE DECISION MADE: 28-MAR-16 Jacksonville FL 32256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle Cook Ireland Ltd. 510(k) NO: K160229(Traditional) ATTN: Lynsey Shine PHONE NO : 011 353 61334440 2657 O' Halloran Road, National TechnolSE DECISION MADE: 21-MAR-16 Limerick IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm COVIDIEN 510(k) NO: K160230(Special) ATTN: TRANG HUYNH PHONE NO : 203 4927473 60 Middletown Avenue SE DECISION MADE: 01-MAR-16 North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OVENT OVENTUS MANUFACTURING PTY LTD 510(k) NO: K160234(Third Party - Traditional) ATTN: Neil Anderson PHONE NO : 61 7 32102913 Suite 8, Level 17 - 141 Queen StreSE DECISION MADE: 17-MAR-16 Brisbane AU 4000 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Cefaly CEFALY TECHNOLOGY 510(k) NO: K160237(Special) ATTN: JEAN-YVES MIGNOLET PHONE NO : 32 436 76722 ZI DES HAUTS SARTS, 4EME AVENUE 5 SE DECISION MADE: 04-MAR-16 HERSTAL BE 4040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K160241(Special) ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694 2951 Ishikawa-cho SE DECISION MADE: 02-MAR-16 Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTEK Duo 31 Fr. Veno-Venous Cannula Set CARDIAC ASSIST, INC. 510(k) NO: K160257(Special) ATTN: GREG JOHNSON PHONE NO : 412 9637770 240 ALPHA DRIVE SE DECISION MADE: 04-MAR-16 PITTSBURGH PA 15238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZELTIQ CoolSculpting System ZELTIQ AESTHETICS, INC. 510(k) NO: K160259(Traditional) ATTN: SHRUTI JAYAKUMAR PHONE NO : 925 4742516 4698 WILLOW ROAD SE DECISION MADE: 23-MAR-16 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECICE Trauma Nail System Ellipse Technologies, Incorporated510(k) NO: K160267(Traditional) ATTN: Cora Sim PHONE NO : 949 8373600 101 Enterprise, Suite 100 SE DECISION MADE: 31-MAR-16 Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Endophys Pressure Sensing Sheath Kit Endophys, Inc. 510(k) NO: K160272(Special) ATTN: Rebecca K Pine PHONE NO : 760 8095178 Thanksgiving Tower, Suite 1930 160SE DECISION MADE: 04-MAR-16 Dallas TX 75201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: truFreeze System CSA MEDIAL, INC. 510(k) NO: K160273(Traditional) ATTN: Sherrie Coval-Goldsmith PHONE NO : 781 5384720 91 HARTWELL AVENUE SE DECISION MADE: 25-MAR-16 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) INSTRUMENTATION LABORATORY CO. 510(k) NO: K160276(Special) ATTN: NIKITA MALLADI PHONE NO : 781 6743245 180 HARTWELL ROAD SE DECISION MADE: 03-MAR-16 BEDFORD MA 01730-2441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 GE Medical Systems Ultrasound and 510(k) NO: K160277(Traditional) ATTN: Tracey Ortiz PHONE NO : 262 6766120 9900 W. Innovation Drive SE DECISION MADE: 25-MAR-16 Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Platinum dRF Imaging System Apelem-DMS Group 510(k) NO: K160301(Special) ATTN: Krishna Mahadea PHONE NO : 33 046 7504900 Parc Scientifique Georges Passe 17SE DECISION MADE: 04-MAR-16 Nimes 30005 FR 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co., Ltd. 510(k) NO: K160336(Traditional) ATTN: Sarah Su PHONE NO : 886 2 82271300 1201 9F, No. 186, Jian Yi Road SE DECISION MADE: 29-MAR-16 Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 QINGDAO HISENSE MEDICAL EQUIPMENT 510(k) NO: K160347(Traditional) ATTN: Liu zhitang PHONE NO : 86 532 55753811 Software outsourcing center 3rd flSE DECISION MADE: 03-MAR-16 Qing dao CN 266101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z-Span Plate System Zavation, LLC 510(k) NO: K160362(Traditional) ATTN: Frankie Cummins PHONE NO : 601 9191119 220 Lakeland Parkway SE DECISION MADE: 22-MAR-16 Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GuideWire FIAGON GMBH 510(k) NO: K160369(Special) ATTN: Dirk Mucha PHONE NO : 49 330 22012110 NEUENDORFSTR. 23 B SE DECISION MADE: 10-MAR-16 HENNIGSDORF DE 16761 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 20G x 1.25" NovaCath Secure IV Catheter System, 24G x 0.56" NovaCath Secure IV Catheter System TANGENT MEDICAL TECHNOLOGIES, INC.510(k) NO: K160374(Special) ATTN: GREG LAST PHONE NO : 734 5274051 8170 JACKSON ROAD, STE A SE DECISION MADE: 11-MAR-16 ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TE7 Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K160381(Special) ATTN: WU ZICUI PHONE NO : 86 755 81885658 MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 09-MAR-16 SHENZHEN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ReadeR, VieweR, QuickScan PSP TRIDENT S.R.L 510(k) NO: K160386(Traditional) ATTN: GIORGIO RIZZO PHONE NO : 39 02 87072380 VIA VERDI 20 SE DECISION MADE: 10-MAR-16 ASSAGO IT 20090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NovaCross Microcatheter Nitiloop Ltd. 510(k) NO: K160389(Special) ATTN: Chanan Schneider PHONE NO : 972 54 6645494 4 Haomanut Street SE DECISION MADE: 11-MAR-16 Netanya IL 4250438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJIFILM FC1 Ultrasound System FUJIFILM SonoSite, Inc. 510(k) NO: K160406(Third Party - Traditional) ATTN: Scott Paulson PHONE NO : 425 9516926 21919 30th Drive SE SE DECISION MADE: 16-MAR-16 Bothell WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AOS Anterolateral Proximal Humeral Plate ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K160409(Special) ATTN: KAZU MIYAHARA PHONE NO : 310 5339966 3203 KASHIWA STREET SE DECISION MADE: 15-MAR-16 TORRANCE CA 90505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Rezum System NxThera, Inc. 510(k) NO: K160417(Special) ATTN: J. Robert Paulson PHONE NO : 763 5150404 7351 Kirkwood Lane N, Suite 138 SE DECISION MADE: 17-MAR-16 Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIMETER Interbody Fusion Device Medtronic Sofamor Danek USA, Inc 510(k) NO: K160418(Special) ATTN: Ankit K. Shah PHONE NO : 901 3963133 1800 Pyramid Place SE DECISION MADE: 07-MAR-16 Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SpeqT Signostics Limited 510(k) NO: K160420(Third Party - Traditional) ATTN: Stewart Bartlett PHONE NO : 61 874 240600 1284 South Road SE DECISION MADE: 21-MAR-16 Clovelly Park AU 5042 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: syngo.via MI Workflows SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K160426(Special) ATTN: Veronica Padharia PHONE NO : 630 8775761 2501 NORTH BARRINGTON RD. SE DECISION MADE: 04-MAR-16 HOFFMAN ESTATES IL 60192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ClearPoint System MRI INTERVENTIONS, INC. 510(k) NO: K160434(Special) ATTN: Peter Piferi PHONE NO : 949 9006833 5 MUSICK SE DECISION MADE: 17-MAR-16 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HemosIL Silica Clotting Time INSTRUMENTATION LABORATORY CO. 510(k) NO: K160445(Special) ATTN: Heather L Harvey PHONE NO : 781 8614549 180 HARTWELL ROAD SE DECISION MADE: 16-MAR-16 BEDFORD MA 01730-2442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip ATRICURE, INC. 510(k) NO: K160454(Special) ATTN: JONATHAN MCELWEE PHONE NO : 513 7554100 6217 CENTRE PARK DRIVE SE DECISION MADE: 18-MAR-16 WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch BIOFIRE DIAGNOSTICS, LLC 510(k) NO: K160457(Special) ATTN: Kristen J. Kanack PHONE NO : 801 7366354 330 390 WAKARA WAY SE DECISION MADE: 15-MAR-16 Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch BIOFIRE DIAGNOSTICS, LLC 510(k) NO: K160462(Special) ATTN: Kristen J. Kanack PHONE NO : 801 7366354 330 390 WAKARA WAY SE DECISION MADE: 17-MAR-16 SALT LAKE CITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Response 5.5 Spine System ORTHOPEDIATRICS CORP. 510(k) NO: K160466(Traditional) ATTN: Mark Fox PHONE NO : 574 2686379 2850 FRONTIER DRIVE SE DECISION MADE: 23-MAR-16 WARSAW IL 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PointerShell Universal, PointerShell LS FIAGON GMBH 510(k) NO: K160479(Special) ATTN: DIRK MUCHA PHONE NO : 49 330 22012110 NEUENDORFSTR. 23 B SE DECISION MADE: 23-MAR-16 HENNIGSDORF DE 16761 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Optetrak Advanced Patella EXACTECH INC 510(k) NO: K160484(Special) ATTN: PATRICK HUGHES PHONE NO : 352 3274762 2320 NW 66TH CT SE DECISION MADE: 18-MAR-16 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Quanta System Surgical Laser fibers QUANTA SYSTEM SPA 510(k) NO: K160513(Special) ATTN: FRANCESCO DELL'ANTONIO PHONE NO : 39 0331 376797 VIA IV NOVEMBRE, 116 SE DECISION MADE: 18-MAR-16 SOLBIATE OLONA (VA) IT 21058 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm ETHICON ENDO-SURGERY, LLC 510(k) NO: K160521(Special) ATTN: Marjorie Medina PHONE NO : 787 7837070 475 CALLE C SE DECISION MADE: 22-MAR-16 GUAYNABO PR 00969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FibroScan 530 Compact ECHOSENS 510(k) NO: K160524(Special) ATTN: KARINE BONENFANT PHONE NO : 33 144 827856 30 Place d'Italie SE DECISION MADE: 18-MAR-16 PARIS FR 75013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANATOMIC PEEK PTC Cervical Fusion System MEDTRONIC SOFAMOR DANEK, USA, INC.510(k) NO: K160528(Traditional) ATTN: LEE GRANT PHONE NO : 901 3963133 1800 PYRAMID PLACE SE DECISION MADE: 28-MAR-16 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cascadia Interbody System K2M 510(k) NO: K160547(Special) ATTN: NANCY GIEZEN PHONE NO : 571 9192000 751 MILLER DR SE SE DECISION MADE: 24-MAR-16 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMV Scientific Schanz Screws SMV SCIENTIFIC 510(k) NO: K160603(Traditional) ATTN: NEPHI ZUFELT PHONE NO : 512 7508622 111 SANDRA MURAIDA WAY UNIT 18A SE DECISION MADE: 28-MAR-16 AUSTIN TX 78703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Visaris Vision® (Vision C, Vision U. Vision V, Vision X) VISARIS D.O.O. BELGRADE 510(k) NO: K160620(Traditional) ATTN: MILAN RATKOVIC PHONE NO : 381 11 2017656 BATAJNICKI DRUM 10 DEO 1B SE DECISION MADE: 30-MAR-16 ZEMUN RS 11080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGNAPioneer GE HEALTHCARE 510(k) NO: K160621(Special) ATTN: GLEN SABIN PHONE NO : 262 5216848 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 29-MAR-16 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Rotatable Snares BOSTON SCIENTIFIC CORPORATION 510(k) NO: K160637(Special) ATTN: Michael Secondini PHONE NO : 508 6836503 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 30-MAR-16 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surefire Infusion System SUREFIRE MEDICAL, INC 510(k) NO: K160662(Third Party - Special) ATTN: Lynne Aronson PHONE NO : 720 3059877 6272 W. 91st Avenue SE DECISION MADE: 11-MAR-16 Westminster CO 80031 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Proxis Ureteral Access Sheath C.R. Bard, Inc. 510(k) NO: K160861(Third Party - Traditional) ATTN: Beatrice Wan PHONE NO : 770 7846414 8195 Industrial Blvd SE DECISION MADE: 31-MAR-16 Covington GA 30014 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
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