510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD June 2016 TOTAL 510(k)s THIS PERIOD 258 TOTAL WITH SUMMARIES 235 TOTAL WITH STATEMENTS 23
DEVICE: ORAL BOND STEINER LABORATORIES 510(k) NO: K142130(Traditional) ATTN: GREGORY G STEINER PHONE NO : 866 3171348 1051 Olsen Street, Building 3611 SE DECISION MADE: 06-JUN-16 Henderson NV 89011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QiF Blood and Fluid Warmer Quality in Flow Ltd. 510(k) NO: K150404(Traditional) ATTN: Neta Sherman PHONE NO : 972 54 6600146 3A Bazel St. POB 10159 SE DECISION MADE: 23-JUN-16 Petach Tikva IL 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-VIEW, IMAGEN EDLEN IMAGING LLC 510(k) NO: K151137(Abbreviated) ATTN: NICK RADACHI PHONE NO : 480 6598430 16441 NORTH 91ST STREET SUITE 102 SE DECISION MADE: 07-JUN-16 SCOTTSDALE AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABC D-FLEX PROBE CONMED CORPORATION 510(k) NO: K151229(Traditional) ATTN: SANDY LECLAIR PHONE NO : 1 315 6243435 525 FRENCH ROAD SE DECISION MADE: 02-JUN-16 UTICA NY 11502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NMI DUAL PORT II NAVILYST MEDICAL, INC. 510(k) NO: K151239(Traditional) ATTN: ROBIN FULLER PHONE NO : 508 6587986 26 FOREST STREET SE DECISION MADE: 06-JUN-16 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Smart Set TOPSPINS, INC. 510(k) NO: K151250(Abbreviated) ATTN: FREDERICK PRINCE PHONE NO : 734 6236400 403 RIVERVIEW DR SE DECISION MADE: 07-JUN-16 ANN ARBOR MI 48107-7205 510(k) STATEMENT DEVICE: Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode OMNITECH SYSTEMS, INC. 510(k) NO: K151976(Traditional) ATTN: JON D. BARRETT PHONE NO : 219 5315532 235 450 SOUTH CAMPBELL ST. SUITE #2 SE DECISION MADE: 27-JUN-16 VALPARAISO IN 46385 510(k) STATEMENT DEVICE: PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter C.R. Bard, Inc 510(k) NO: K151985(Traditional) ATTN: Bryan Stone PHONE NO : 801 5225000 5876 605 North 5600 West SE DECISION MADE: 14-JUN-16 Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K151986(Traditional) ATTN: MATTHEW GEE PHONE NO : 914 5242099 511 BENEDICT AVENUE SE DECISION MADE: 29-JUN-16 TARRYTOWN NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DCI Edge Dental Chair with Operative Unit DCI 510(k) NO: K151987(Traditional) ATTN: ROBERT BELLINGHAM PHONE NO : 503 5372431 305 N. SPRINGBROOK RD. SE DECISION MADE: 01-JUN-16 NEWBERG OR 97132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lucent Intervertebral Body Fusion Device Spinal Elements Inc. 510(k) NO: K152011(Traditional) ATTN: Julie Lamothe PHONE NO : 760 6071816 3115 Melrose Dr., Suite 200 SE DECISION MADE: 09-JUN-16 Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K152122(Traditional) ATTN: MICHAEL CHANG-CHIEN PHONE NO : 858 5133888 13200 GREGG ST. SE DECISION MADE: 24-JUN-16 POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADspeed Pro SHIMADZU CORPORATION 510(k) NO: K152244(Traditional) ATTN: Toshio Kadowaki PHONE NO : 81 75823 1305 1 Nishinokyo-Kuwabaracho Nakagyo-kSE DECISION MADE: 20-JUN-16 Kyoto JP 604-8511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aquarius Stoma Measuring Device DEGANIA SILICONE LTD 510(k) NO: K152246(Traditional) ATTN: ZOYA LEE PHONE NO : 97 216 755122 SE DECISION MADE: 21-JUN-16 DEGANIA BET IL 1513000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Endobronchial Tube HENAN TUOREN MEDICAL DEVICE CO., L510(k) NO: K152251(Traditional) ATTN: MEIZI ZHANG PHONE NO : 0086 1363 3736073 WEIYUAN INDUSTRIAL ZONE, MENGGANG,SE DECISION MADE: 10-JUN-16 XINXIANG CN 453400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Wing Smart FEVI and Peak Flow Meter Sparo Inc. 510(k) NO: K152276(Traditional) ATTN: Mona Dean PHONE NO : 911 Washington Ave, #809 SE DECISION MADE: 03-JUN-16 Saint Louis MO 63101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Background Pattern Classification [BPc(TM)] Natus Medical Incorporated DBA Exc510(k) NO: K152301(Traditional) ATTN: Sanjay Mehta PHONE NO : 905 2875055 2568 Bristol Circle SE DECISION MADE: 03-JUN-16 Oakville CA L6H5S1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Unifine Pentips/ Unifine Pentips Plus OWEN MUMFORD LTD 510(k) NO: K152339(Traditional) ATTN: Patty Cronan PHONE NO : 011 44 1993812021 BROOK HILL SE DECISION MADE: 24-JUN-16 WOODSTOCK GB OX20 ITU 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover ST. JUDE MEDICAL 510(k) NO: K152342(Traditional) ATTN: PARITA MEHTA PHONE NO : 651 7564442 6901 PRESTON ROAD SE DECISION MADE: 09-JUN-16 PLANO TX 75024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Regular and Special Umbilical Cord Clamp and Cutter NINGBO FEITE MEDICAL DEVICE CO., L510(k) NO: K152350(Traditional) ATTN: CHARLES SHEN PHONE NO : 086 0574 88216088 TONGPENZHA, ZHONGGONGMIAO STREET, SE DECISION MADE: 28-JUN-16 NINGBO CN 315192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Gemini Bonded Sterilization Wrap MEDLINE INDUSTRIES, INC. 510(k) NO: K152458(Traditional) ATTN: Jennifier Mason PHONE NO : 847 6433652 ONE MEDLINE PLACE SE DECISION MADE: 01-JUN-16 MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Spinal Jaxx Interbody Fusion Device NEUROPRO SPINAL JAXX, INC. 510(k) NO: K152501(Traditional) ATTN: BENJAMIN J. REMINGTON PHONE NO : 209 5455111 4707 GREENLEAF CT., STE. C SE DECISION MADE: 29-JUN-16 MODESTO CA 95356 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTR550 (Tentative) Antimicrobial Silver Wound Gel MEDICAL TECHNOLOGY RESEARCH INC. 510(k) NO: K152519(Traditional) ATTN: Bhalchandra M. Karandikar PHONE NO : 503 9026279 2650 PROGRESS WAY SE DECISION MADE: 02-JUN-16 WOODBURN OR 97071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Seal Rite Non-Rebreathing Valve The Lifeguard Store, Inc. 510(k) NO: K152521(Traditional) ATTN: Amy Hilten PHONE NO : 309 4515858 2012 W. College Ave. SE DECISION MADE: 03-JUN-16 Normal IL 61761 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Communicator Surgical Facemask with Clear Window Prestige Ameritech, Ltd 510(k) NO: K152561(Abbreviated) ATTN: Rex Reese PHONE NO : 817 4272700 7201 Iron Horse Blvd. SE DECISION MADE: 03-JUN-16 North Richland Hills TX 76180 510(k) STATEMENT DEVICE: Anker II Dental Implant System Alliance Global Technology Co., Lt510(k) NO: K152576(Traditional) ATTN: YAYUAN CHANG PHONE NO : 886 76 956688 2F., No.92, Luke 5th Rd. SE DECISION MADE: 02-JUN-16 Kaohsiung TW 82151 510(k) STATEMENT DEVICE: Resmon PRO FULL MEDICAL GRAPHICS CORP. 510(k) NO: K152585(Traditional) ATTN: JIM PURDIE PHONE NO : 651 7663358 350 OAK GROVE PARKWAY SE DECISION MADE: 24-JUN-16 ST. PAUL MN 55127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ProteXsure Safety Capsule System StarCap Medical LLC ( DBA Prism Me510(k) NO: K152597(Traditional) ATTN: Les Capella PHONE NO : 754 8021990 9604 Exbury Court SE DECISION MADE: 08-JUN-16 Parkland FL 33076 510(k) STATEMENT DEVICE: Collagen Dental Wound Dressings COLLAGEN MATRIX, INC. 510(k) NO: K152600(Traditional) ATTN: GLORIA ZUCLICH PHONE NO : 201 4051477 15 THORNTON ROAD SE DECISION MADE: 23-JUN-16 OAKLAND NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Jeesung Safety Syringe and Single Use Needles JEESUNG MEDICAL CO LTD 510(k) NO: K152606(Traditional) ATTN: Choi Yong Hyun PHONE NO : 82 429 326061 54, MUJINI 1-GIL, DAEDEOK-GU SE DECISION MADE: 28-JUN-16 DAEJEON KR 306-130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls INOVA DIAGNOSTICS, INC. 510(k) NO: K152635(Traditional) ATTN: Gabriella Lakos PHONE NO : 858 5869900 1393 9900 OLD GROVE RD. SE DECISION MADE: 01-JUN-16 SAN DIEGO CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATOVEN-Reusable Laser Fiber DIOTECH CO 510(k) NO: K152667(Traditional) ATTN: LEE KYUNG YONG PHONE NO : 82 51 2926237 301, NAKDONG-DAERO, SAHA-GU SE DECISION MADE: 09-JUN-16 BUSAN KR 604812 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LightLas Multi-Wavelength Medical Laser System LIGHTMED CORPORATION 510(k) NO: K152688(Traditional) ATTN: Mollie Li PHONE NO : 886 2 26881726 No. 1-1, Lane 1, Pao-An St., Sec 3SE DECISION MADE: 15-JUN-16 New Taipei City TW 23861 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPERIMETER MP-3 NIDEK CO., LTD. 510(k) NO: K152729(Traditional) ATTN: YONEJI MIZUNO PHONE NO : 81 533 678901 34-14 MAEHAMA, HIROISHI-CHO SE DECISION MADE: 06-JUN-16 GAMAGORI JP 443-0038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Kerrison Rongeurs VITALITEC MEDIZINTECHNIK GMBH 510(k) NO: K152734(Traditional) ATTN: LYNETTE HOWARD PHONE NO : 49 07424 92206 STEIGAECKER 20 SE DECISION MADE: 18-JUN-16 BALGHEIM (BADEN-WURTTEM BERG) DE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lite Touch FOCUS MEDICAL LLC 510(k) NO: K152737(Traditional) ATTN: JOHN B LEE PHONE NO : 203 7308885 23 FRANCIS J. CLARKE CIRCLE SE DECISION MADE: 29-JUN-16 BETHEL CT 06801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIEGO ELITE DRILL GYRUS ACMI, INC 510(k) NO: K152744(Traditional) ATTN: DOLAN MILLS PHONE NO : 901 3730236 136 TURNPIKE ROAD SE DECISION MADE: 10-JUN-16 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DSG Threaded Drill System SPINEGUARD, S.A. 510(k) NO: K152747(Traditional) ATTN: STEPHANE BETTE PHONE NO : 33 1 45184519 10 COURS LOUIS LUMIERE SE DECISION MADE: 10-JUN-16 VINCENNES FR 94300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long SUMITOMO BAKELITE CO., LTD. 510(k) NO: K152771(Traditional) ATTN: SHIRO AGEHAMA PHONE NO : 81 3 54624811 5-8, HIGASHI-SHINAGAWA 2- CHOME, SSE DECISION MADE: 17-JUN-16 TOKYO JP 140-0002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A Plus Internal Fixture System T-PLUS IMPLANT TECH. CO., LTD. 510(k) NO: K152786(Traditional) ATTN: DANA CHENG PHONE NO : 866 2 22981950 NO.41, WUQUAN 6TH RD., WUGU DIST.,SE DECISION MADE: 07-JUN-16 NEW TAIPEI CITY TW 24889 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Liger Medical HTU-110 LIGER MEDICAL, LLC 510(k) NO: K152843(Traditional) ATTN: STEVE SMITH PHONE NO : 801 2310954 14062 S RUNNING CREEK WAY SE DECISION MADE: 24-JUN-16 DRAPER UT 84020 510(k) STATEMENT DEVICE: Helios III LASEROPTEK CO. LTD. 510(k) NO: K152856(Traditional) ATTN: HONG CHU PHONE NO : 82 31 7379885 8 204 HYNDAI I-VALLEY 223-12 SANGDAISE DECISION MADE: 02-JUN-16 SUNGNAM-SI KR 462-714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Portable ECG Monitor CONTEC MEDICAL SYSTEMS CO., LTD 510(k) NO: K152863(Traditional) ATTN: XUEYONG LI PHONE NO : 86 335 8015489 NO. 112 QINHUANG WEST STREET, ECONSE DECISION MADE: 22-JUN-16 QINHUANGDAO CN 066004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SureFine Pen Needle SHINA MED CORPORATION 510(k) NO: K152877(Traditional) ATTN: SUNG-SOON PARK PHONE NO : 82 31 80572125 455-30, BOGAEWONSAM-RO, BOGAE-MYUNSE DECISION MADE: 07-JUN-16 ANSEONG-SI KR 456-871 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DermaTherapy Bed Linens PRECISION FABRICS GROUP, INC. 510(k) NO: K152884(Traditional) ATTN: Terry Montgomery PHONE NO : 336 5108009 301 N. ELM ST. SUITE 600 SE DECISION MADE: 20-JUN-16 GREENSBORO NC 27401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Corin Optimized Positioning System (OPS) CORIN USA 510(k) NO: K152893(Traditional) ATTN: Kathy Trier PHONE NO : 813 3029604 5670 W. CYPRESS ST. SUITE C SE DECISION MADE: 03-JUN-16 TAMPA FL 33607 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Gun Oil, Pink, Gun Oil H2O, Pink Water EMPOWERED PRODUCTS, INC. 510(k) NO: K152918(Traditional) ATTN: MATT CARR PHONE NO : 702 2161321 3367 W. OQUENDO RD. SE DECISION MADE: 02-JUN-16 LAS VEGAS NV 89118 510(k) STATEMENT DEVICE: EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented ECO MEDI GLOVE SDN. BHD. 510(k) NO: K152937(Traditional) ATTN: SURESH KUMAR PHONE NO : 603 602 83033 LOT 23826, JALAN TEMBAGA KUNING, SE DECISION MADE: 23-JUN-16 KUMUNTING PERAK MY 34600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALIDATE D-Dimer Calibration Verification/Linearity Test Kit MAINE STANDARDS COMPANY LLC 510(k) NO: K152961(Traditional) ATTN: JAMES CHAMPLIN PHONE NO : 207 8921300 221 US ROUTE 1 SE DECISION MADE: 03-JUN-16 CUMBERLAND FORESIDE ME 04110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NERBRIDGE TOYOBO CO., LTD. 510(k) NO: K152967(Traditional) ATTN: YUTA KAWAKATSU PHONE NO : 81 663 483336 2-8 DOJIMA HAMA 2- CHOME SE DECISION MADE: 22-JUN-16 KITA-KU JP 530-8230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes BIO PROTECH, INC. 510(k) NO: K152984(Traditional) ATTN: DANIEL WOO PHONE NO : 82 33 7357720 DONGHWA MEDICAL INSTRUMENT COMPLEXSE DECISION MADE: 03-JUN-16 WONJU-SI KR 220-801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter STERILMED, INC. 510(k) NO: K153006(Traditional) ATTN: PATRICIA F KAUFMAN PHONE NO : 763 4883211 5010 Cheshire Parkway N, Suite 2 SE DECISION MADE: 23-JUN-16 Plymouth MN 55446 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELALUX 3 VOCO GMBH 510(k) NO: K153018(Traditional) ATTN: M TH. PLAUMANN PHONE NO : 49 4721 719219 Anto-Flettner-Str. 1-3 SE DECISION MADE: 23-JUN-16 Cuxhaven DE 27472 510(k) STATEMENT DEVICE: Digital Blood Pressure Monitor SUZHOU SUNSPIRI CO., LTD. 510(k) NO: K153033(Traditional) ATTN: JING ZHANG PHONE NO : 86 512 68238996 NO. 72, HENGSHAN RD., SUZHOU NEW DSE DECISION MADE: 24-JUN-16 SUZHOU CN 215009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NobelDesign Software NOBEL BIOCARE AB 510(k) NO: K153036(Traditional) ATTN: CHARLEMAGNE CHUA PHONE NO : 714 2824800 7830 BOX 5190, SE-402 26, VASTRA HAMNAGSE DECISION MADE: 02-JUN-16 GOTEBORG SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hermes Medical Imaging Suite v5.6 HERMES MEDICAL SOLUTIONS, AB 510(k) NO: K153056(Traditional) ATTN: JOAKIM ARWIDSON PHONE NO : 46 819 0325 SKEPPSBRON 44 SE DECISION MADE: 01-JUN-16 STOCKHOLM SE 11130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FitRite™ Total Hip Arthroplasty System EXCERA ORTHOPEDICS, INC. 510(k) NO: K153057(Traditional) ATTN: SCOTT COLERIDGE PHONE NO : 1188 Centre St SE DECISION MADE: 23-JUN-16 Newton MA 02459 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "silky" II POLYDEK, "cottony" II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL Teleflex Medical, Inc. 510(k) NO: K153076(Traditional) ATTN: Natalie Hichak PHONE NO : 919 4338049 3015 Carrington Mill Blvd SE DECISION MADE: 16-JUN-16 Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LED Curing Light GT-2000 MONITEX INDUSTRIAL CO., LTD. 510(k) NO: K153078(Traditional) ATTN: Shu-Lung Wang PHONE NO : 886 2 29993869 6F, 70 SEC. 1 GUANG-FU ROAD SAN-CHSE DECISION MADE: 28-JUN-16 NEW TAIPEI CITY TW 241-58 510(k) STATEMENT DEVICE: ASAHI Fielder XT-A, ASAHI Fielder XT-R ASAHI INTECC CO., LTD. 510(k) NO: K153106(Traditional) ATTN: Yoshihiko Fukui PHONE NO : 81 52 7681211 1703 WAKITA-CHO, MORIYAMA-KU SE DECISION MADE: 21-JUN-16 NAGOYA JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner SIGNATURE ORTHOPAEDICS PTY LTD. 510(k) NO: K153131(Traditional) ATTN: DECLAN BRAZIL PHONE NO : 61 2 94285181 7 SIRIUS ROAD SE DECISION MADE: 03-JUN-16 LANE COVE AU 2066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Initial LiSi Press GC AMERICA INC. 510(k) NO: K153136(Traditional) ATTN: MARK HEISS PHONE NO : 708 5970900 3737 W. 127TH STREET SE DECISION MADE: 30-JUN-16 ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LunulaLaser ERCHONIA MEDICAL, INC. 510(k) NO: K153164(Traditional) ATTN: STEVE SHANKS PHONE NO : 214 5442227 2021 COMMERCE DR. SE DECISION MADE: 03-JUN-16 MCKINNEY TX 75069 510(k) STATEMENT DEVICE: NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit ASTUTE MEDICAL, INC 510(k) NO: K153165(Special) ATTN: Karin Hughes PHONE NO : 858 5007044 3550 GENERAL ATOMICS COURT BUILDINSE DECISION MADE: 01-JUN-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Admira Fusion Flow VOCO GMBH 510(k) NO: K153177(Traditional) ATTN: MANFRED THOMAS PLAUMANN PHONE NO : 49 4 7217190 ANTON-FLETTNER-STR. 1-3 SE DECISION MADE: 30-JUN-16 CUXHAVEN DE 27472 510(k) STATEMENT DEVICE: MAIA CENTERVUE SPA 510(k) NO: K153181(Traditional) ATTN: ROBERTO GABRIOTTI PHONE NO : 39 049 7396147 VIA SAN MARCO 9H SE DECISION MADE: 08-JUN-16 PADOVA IT 35129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System SD BIOSENSOR 510(k) NO: K153201(Special) ATTN: Yeon Park PHONE NO : 82 31 3000416 C-4th & 5th, 16, Deogyeong-daero, SE DECISION MADE: 24-JUN-16 Suwon-si KR 443-813 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Masimo Root Monitoring System and Accessories Masimo Corporation 510(k) NO: K153225(Traditional) ATTN: Marguerite Thomlinson PHONE NO : 949 2977000 52 Discovery SE DECISION MADE: 21-JUN-16 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MySpine Pedicle Screw Placement Guides - LP Medacta International SA 510(k) NO: K153273(Traditional) ATTN: Michael G Loiterman PHONE NO : 41 91 6966060 Strada Regina SE DECISION MADE: 29-JUN-16 Castel San Pietro CH ch 6874 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PowerGlide Pro Midline Catheter C.R. BARD, INC. 510(k) NO: K153280(Traditional) ATTN: CASEY COOMBS PHONE NO : 801 5225869 605 NORTH 5600 WEST SE DECISION MADE: 02-JUN-16 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Voyant Open Fusion Device APPLIED MEDICAL RESOURCES 510(k) NO: K153288(Traditional) ATTN: JESSICA CHO PHONE NO : 949 7137958 22872 Avenida Empresa SE DECISION MADE: 01-JUN-16 Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCATTER CORRECTION FOR CXDI SERIES CANON, INC 510(k) NO: K153312(Traditional) ATTN: SHINJI MORI PHONE NO : 81 3 37582111 30-2 SHIMOMARUKO, 3-CHROME, OHTA-KSE DECISION MADE: 28-JUN-16 TOKYO JP 146-8501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Quantib Brain 1 QUANTIB BV 510(k) NO: K153351(Traditional) ATTN: FLOOR VAN LEEUWEN PHONE NO : 31 10 8411749 WESTBLAAK 106 SE DECISION MADE: 17-JUN-16 ROTTERDAM NL NL-3012 KM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SANDMAN ELITE EMBLA SYSTEMS 510(k) NO: K153353(Traditional) ATTN: SHANE T. SAWALL PHONE NO : 613 2548877 1301 1 HINES ROAD SUITE 202 SE DECISION MADE: 23-JUN-16 KANATA CA K2K 3C7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADMIRE SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K153360(Traditional) ATTN: JOHN URTZ PHONE NO : 610 4486002 40 LIBERTY BOULEVARD MAIL CODE 65-SE DECISION MADE: 29-JUN-16 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S698 Symbioz flow SOPRO - ACTEON GROUP 510(k) NO: K153367(Traditional) ATTN: Philippe BOYER PHONE NO : 011 33 442980101 ZAC ATHELIA IV AVENUE DES GENEVRIESE DECISION MADE: 17-JUN-16 LA CIOTAT FR 13705 510(k) STATEMENT DEVICE: Repagyn vaginal suppositories FARMA-DERMA S.R.L. 510(k) NO: K153372(Traditional) ATTN: MARA CALZOLARI PHONE NO : 39 051 6814181 VIA DEI BERSAGLIERI,10 SE DECISION MADE: 30-JUN-16 SALA BOLOGNESE IT 40010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System ORTHOCARE 510(k) NO: K153374(Traditional) ATTN: RAJEEV CHHABRA PHONE NO : 91 11 41424511 3/10 KIRTI NAGAR INDUSTRIAL AREA SE DECISION MADE: 17-JUN-16 NEW DELHI IN 110015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle GUANGZHOU IMPROVE MEDICAL INSTRUME510(k) NO: K153388(Traditional) ATTN: BANGFU SUN PHONE NO : 86 20 32312660 NO. 102, KAIYUAN AVENUE, SCIENCE CSE DECISION MADE: 07-JUN-16 GUANGZHOU CN 510530 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sophono Bone Conduction Systems (S) Configuration and (M) Configuration SOPHONO INC. 510(k) NO: K153391(Traditional) ATTN: Rozanne Paciej PHONE NO : 904 3328233 5744 CENTRAL AVE #100 SE DECISION MADE: 16-JUN-16 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PowerMidline Catheter C.R. BARD, INC 510(k) NO: K153393(Traditional) ATTN: Casey Coombs PHONE NO : 801 5225869 605 NORTH 5600 WEST SE DECISION MADE: 28-JUN-16 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pall-Aquasafe Water Filter PALL INTERNATIONAL, SARL 510(k) NO: K153434(Traditional) ATTN: KAREN D PETERSON-DOYLE PHONE NO : 516 8019267 AVE DE TIVOLI3 SE DECISION MADE: 10-JUN-16 FRIBOURG CH 1700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATERAL Spine Truss System 4Web, Inc. 510(k) NO: K153436(Traditional) ATTN: Jessee Hunt PHONE NO : 800 2857090 6170 Research Rd., Suite 219 SE DECISION MADE: 06-JUN-16 Frisco TX 75033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Megapulse III Shortwave Diathermy Accelerated Care Plus 510(k) NO: K153456(Traditional) ATTN: Patrick Parker PHONE NO : 800 3501100 1827 4999 Aircenter Circle, Suite 103 SE DECISION MADE: 14-JUN-16 Reno NV 89502 510(k) STATEMENT DEVICE: Quiver Laparoscopic Extendable ITL Corporation PTY LTD 510(k) NO: K153472(Traditional) ATTN: Emily Rossiter PHONE NO : 61 3 87733050 1/63 Wells Road SE DECISION MADE: 23-JUN-16 Chelsea Heights, VIC AU 3196 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Surgical Face Mask XIANTAO RAYXIN MEDICAL PRODUCTS CO510(k) NO: K153496(Traditional) ATTN: Liang Zhang PHONE NO : 86 728 2617592 NO. 258 PENGCHANG ROAD, MIDDLE STRSE DECISION MADE: 15-JUN-16 Xiantao CN 433018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AnyPlus® Cervical PEEK Cage System GS Medical Co., Ltd. 510(k) NO: K153517(Traditional) ATTN: Milan George PHONE NO : 90, Osongsaengmyeong 4-ro SE DECISION MADE: 24-JUN-16 Osong-eup, Cheongwon-gun KR 363-9510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medipure Oxygen-LC System PRAXAIR DISTRIBUTION, INCORPORATED510(k) NO: K153518(Special) ATTN: Michael Skrjanc PHONE NO : 330 9493324 175 EAST PARK DRIVE SE DECISION MADE: 03-JUN-16 TONAWANDA NY 14150 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NobelProcera HT ML Full Contour Zirconia Crown NOBEL BIOCARE AB 510(k) NO: K153534(Traditional) ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830 BOX 5190, SE-402 26, VASTRA HAMNAGSE DECISION MADE: 06-JUN-16 GOTEBORG SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sol-M Insulin Syringe, Sol-M TB Syringe SOL-MILLENNIUM MEDICAL, INC. 510(k) NO: K153537(Traditional) ATTN: Jim Barley PHONE NO : 949 4333058 1735 North Brown Road, Suite 100 SE DECISION MADE: 17-JUN-16 Lawrenceville GA 30043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Portable Slit Lamp SHANGHAI BOLAN OPTICAL-ELECTRIC CO510(k) NO: K153545(Traditional) ATTN: Johnny Hu PHONE NO : 86 21 69225166 NO.29, Jiuyuan Road, Qingpu IndustSE DECISION MADE: 22-JUN-16 Shanghai CN 201700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGE Automatic Upper Arm Blood Pressure Monitor Ageless Health Industrial Co., Ltd510(k) NO: K153552(Traditional) ATTN: Victor Wan PHONE NO : 86 769 81158038 3/F, A1 Bldg Dongshen Sima IndustSE DECISION MADE: 01-JUN-16 Dongguan CN 523560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml LIOFILCHEM S.R.L 510(k) NO: K153569(Traditional) ATTN: Fabio Brocco PHONE NO : 39 085 8930745 64026 ROSETO DEGLI SE DECISION MADE: 22-JUN-16 ABRUZZI IT 510(k) STATEMENT DEVICE: LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application SMITH & NEPHEW 510(k) NO: K153606(Traditional) ATTN: JANICE HASELTON PHONE NO : 978 7491494 150 MINUTEMAN ROAD SE DECISION MADE: 02-JUN-16 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROMA Calculation Tool Using Elecsys Assays ROCHE DIAGNOSTICS 510(k) NO: K153607(Traditional) ATTN: Angelo Pereira PHONE NO : 317 5213544 9115 HAGUE ROAD SE DECISION MADE: 15-JUN-16 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device Ethicon, LLC 510(k) NO: K153611(Traditional) ATTN: Marjorie Medina PHONE NO : 1 908 2182113 475 C Street SE DECISION MADE: 03-JUN-16 Los Frailes Industrial Park, Suite510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Endoform Reconstructive Template Aroa Biosurgery Limited (Formerly 510(k) NO: K153632(Traditional) ATTN: Yasmin Rai PHONE NO : 64 9 8693035 2 Kingsford Smith Place, Airport OSE DECISION MADE: 16-JUN-16 Auckland NZ 2022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITA ENAMIC Implant Solutions (IS) VITA ZAHNFABRIK H. RAUTER GMBH CO.510(k) NO: K153645(Abbreviated) ATTN: BERND WALKER PHONE NO : 49 776 1562361 Spitelgasse 3 SE DECISION MADE: 30-JUN-16 Bad Sackingen DE D-79713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set TELEFLEX INC. 510(k) NO: K153652(Traditional) ATTN: CHET JONES PHONE NO : 919 4332579 3015 CARRINGTON MILL BLVD SE DECISION MADE: 21-JUN-16 MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MaxO2ME MAXTEC, LLC 510(k) NO: K153659(Traditional) ATTN: JERALD WILSON PHONE NO : 1 385 5498070 2305 South 1070 West SE DECISION MADE: 10-JUN-16 Salt Lake City UT 841119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Chocolate XD PTCA Balloon Catheter TriReme Medical, LLC 510(k) NO: K153682(Traditional) ATTN: Shiva Ardakani PHONE NO : 925 9311300 7060 Koll Center Parkway, Suite 30SE DECISION MADE: 23-JUN-16 Pleasanton CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERIZONE Sterilizer TSO3 INC 510(k) NO: K153689(Traditional) ATTN: NATHALIE RACETTE PHONE NO : 418 6510003 294 2505, AVENUE DALTON SE DECISION MADE: 30-JUN-16 QUEBEC CA G1P 3S5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer INFRARED LABORATORY SYSTEMS, LLC (510(k) NO: K153692(Traditional) ATTN: JULIE PASCHAL PHONE NO : 317 8961565 17408 TILLER COURT SUITE 1900 SE DECISION MADE: 24-JUN-16 WESTFIELD IN 40674 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M3290B Philips IntelliVue Information Center iX PHILIPS MEDICAL SYSTEMS 510(k) NO: K153702(Traditional) ATTN: THERESA POOLE PHONE NO : 978 6597621 3000 MINUTEMAN ROAD SE DECISION MADE: 13-JUN-16 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Strive DJO, LLC 510(k) NO: K153704(Abbreviated) ATTN: Rand Daoud PHONE NO : 760 7343037 1430 DECISION ST. SE DECISION MADE: 03-JUN-16 VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Getinge Series Warming Cabinet GETINGE SOURCING, LLC 510(k) NO: K153713(Traditional) ATTN: BARB SMITH PHONE NO : 585 2146049 1777 EAST HENRIETTA ROAD SE DECISION MADE: 07-JUN-16 ROCHESTER NY 14623 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream HONEYWELL HOMMED, LLC 510(k) NO: K153719(Traditional) ATTN: Greg Lillegard PHONE NO : 262 2526062 3400 INTERTECH DR. SUITE 200 SE DECISION MADE: 03-JUN-16 BROOKFIELD WI 53045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control Abbott Laboratories 510(k) NO: K153730(Traditional) ATTN: Laura Yelvigi Joglekar PHONE NO : 224 6673503 Dept 09AA, Bldg. AP 8, 100 AbbottSE DECISION MADE: 15-JUN-16 Abbott Park IL 60064-6038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRI Patient Monitor TeslaDUO MIPM MAMMENDORFER INSTITUT FUR PHY510(k) NO: K153739(Traditional) ATTN: HANS SCHWAIGER PHONE NO : OSKAR-VON-MILLER-STR. 6 SE DECISION MADE: 28-JUN-16 MAMMENDORF DE 82291 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RTHawk, HeartVista Cardiac Package HeartVista, Inc. 510(k) NO: K153740(Traditional) ATTN: James J Rogers PHONE NO : 650 8007937 4984 El Camino Real, Suite 102 SE DECISION MADE: 30-JUN-16 Los Altos CA 94022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3 Series Phototherapy Unit DAAVLIN DISTRIBUTING COMPANY 510(k) NO: K153749(Special) ATTN: MICHELE THIEL PHONE NO : 419 6366304 205 WEST BEMENT STREET SE DECISION MADE: 30-JUN-16 BRYAN OH 43506 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Contact Lens Case (multiple brand name) DANYANG CHANXIN GLASSES CASES FACT510(k) NO: K160005(Traditional) ATTN: LEMON CHEN PHONE NO : 86 511 86903193 HUADIAN CHUANGYE PARK, DANGUI ROADSE DECISION MADE: 07-JUN-16 DANYANG CITY CN 212300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O-pel Laser and families of probe delivery devices PRECISE LIGHT SURGICAL 510(k) NO: K160012(Traditional) ATTN: KEN ARNOLD PHONE NO : 844 6691845 310 W. HAMILTON AVE SUITE 210 SE DECISION MADE: 02-JUN-16 CAMPBELL CA 95008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arrow Quickflash Arterial Catheterization Device ARROW INTERNATIONAL, INC. (SUBSIDI510(k) NO: K160018(Traditional) ATTN: TRACY LARISH PHONE NO : 610 3780131 2400 BERNVILLE RD SE DECISION MADE: 13-JUN-16 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis Biomet, Inc. 510(k) NO: K160071(Traditional) ATTN: Carmen Albany PHONE NO : 574 3713024 56 East Bell Drive SE DECISION MADE: 16-JUN-16 Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz Simple Science, LLC 510(k) NO: K160095(Traditional) ATTN: Eoin Croke PHONE NO : 612 3674540 5555 W 78th St STE M SE DECISION MADE: 10-JUN-16 Edina MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEREC SpeedGlaze Sirona Dental Systems GmbH 510(k) NO: K160099(Traditional) ATTN: Thomas Diesch PHONE NO : 49 6251 160 Fabrikstrasse 31 SE DECISION MADE: 02-JUN-16 Bensheim DE 64625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Heat Pain Pro OMRON HEALTHCARE, INC. 510(k) NO: K160115(Traditional) ATTN: RENEE Thornborough PHONE NO : 847 2475626 1925 WEST FIELD COURT SE DECISION MADE: 03-JUN-16 LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NobelSpeedy Groovy NOBEL BIOCARE AB 510(k) NO: K160119(Traditional) ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830 VASTRA HAMNGATAN 1 SE DECISION MADE: 02-JUN-16 GOTEBORG SE se-411 17 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BloodSTOP iX Battle Matrix LifeSciencePLUS Inc. 510(k) NO: K160130(Traditional) ATTN: Audrey Vitale PHONE NO : 650 5658172 2520A Wyandotte St. SE DECISION MADE: 29-JUN-16 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OEC Elite MiniView GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K160131(Traditional) ATTN: LIFENG WANG PHONE NO : 86 105 8068888 70252 NO.1 YONGCHANG NORTH ROAD, BEIJINGSE DECISION MADE: 21-JUN-16 BEIJING CN 100176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: StatStrip Xpress Blood Glucose Monitoring System NOVA BIOMEDICAL CORPORATION 510(k) NO: K160156(Traditional) ATTN: Eliza Wang PHONE NO : 781 6473700 743 200 PROSPECT STREET SE DECISION MADE: 23-JUN-16 WALTHAM MA 02454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: The Life Spine Subtalar Implant System Life Spine 510(k) NO: K160169(Traditional) ATTN: Randy Lewis PHONE NO : 847 8846117 13951 S Quality Drive SE DECISION MADE: 23-JUN-16 Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lehman Manometry Catheter Wilson-Cook Medical, Inc. 510(k) NO: K160170(Special) ATTN: Doris A. Hawks PHONE NO : 336 7440157 6293 4900 Bethania Station Road SE DECISION MADE: 20-JUN-16 Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BSD4343 Digital Flat Panel X-ray Detector BONTECH INC. 510(k) NO: K160204(Traditional) ATTN: Kwang S. Choi PHONE NO : 82 31 3035254 Youngtong-gu Youngtong-dong 980-3,SE DECISION MADE: 09-JUN-16 Suwon-si KR 443-702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Gold Anchor NASLUND MEDICAL AB 510(k) NO: K160209(Traditional) ATTN: Tomas Naslund PHONE NO : 46 73 2620717 VASSVAGEN 21 SE DECISION MADE: 21-JUN-16 HUDDINGE SE 14139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: s-Clean Tapered II RBM Implant System Dentis Co., Ltd. 510(k) NO: K160213(Traditional) ATTN: Sun Chul Shin PHONE NO : 82 53 5822804 99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 21-JUN-16 Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Barrier Sleeves and Covers DENTSPLY International Inc. 510(k) NO: K160232(Traditional) ATTN: Helen Lewis PHONE NO : 717 4871332 221 West Philadephia Street, SuiteSE DECISION MADE: 07-JUN-16 York PA 17408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ViaValve Safety I.V. Catheter SMITHS MEDICAL ASD, INC. 510(k) NO: K160235(Traditional) ATTN: BRIAN FARIAS PHONE NO : 603 3523812 2493 201 WEST QUEEN STREET SE DECISION MADE: 30-JUN-16 SOUTHINGTON CT 06489 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Airborne Phototherapy Light INTERNATIONAL BIOMEDICAL 510(k) NO: K160238(Abbreviated) ATTN: Amy Pieper PHONE NO : 512 8730033 8206 CROSS PARK DR. SE DECISION MADE: 14-JUN-16 AUSTIN TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIOunite Thommen Medical AG 510(k) NO: K160244(Traditional) ATTN: Daniel Snetivy PHONE NO : 41 61 9659020 Neckarsulmstrasse 28 SE DECISION MADE: 02-JUN-16 Grenchen CH 2540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Additive Orthopaedics Hammertoe Correction System Additive Orthopaedics, LLC 510(k) NO: K160264(Traditional) ATTN: Greg Kowalczyk PHONE NO : 732 8826633 83 Amelia Circle SE DECISION MADE: 01-JUN-16 Little Silver NJ 07739 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Image Navigator by Immuno Concepts Immuno Concepts, NA, Ltd. 510(k) NO: K160265(Traditional) ATTN: Eric S. Hoy PHONE NO : 214 4610784 9825 Goethe Road; Suite 350 SE DECISION MADE: 17-JUN-16 Sacramento CA 95827 510(k) STATEMENT DEVICE: Advanced Medical Imaging Software Suite (KSWVWR) KEOSYS SAS 510(k) NO: K160334(Traditional) ATTN: Laurence BOY-MACHEFER PHONE NO : 33 0253 591290 13 Impasse Serge Reggiani SE DECISION MADE: 21-JUN-16 SAINT HERBLAIN FR 44815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECG CT Gating Device NEOCOIL, LLC 510(k) NO: K160350(Traditional) ATTN: MICHAEL LEIGH PHONE NO : 262 3471250 N27 W23910A PAUL RD. SE DECISION MADE: 16-JUN-16 PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VersaWrap Tendon Protector Alafair Biosciences Inc 510(k) NO: K160364(Traditional) ATTN: Ben Walthall PHONE NO : 512 4304967 3925 W. Braker Lane, Floor #3 SE DECISION MADE: 10-JUN-16 Austin TX 78759 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K160370(Traditional) ATTN: Zeng Zhe PHONE NO : 86 755 81885672 MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 09-JUN-16 SHENZHEN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Miromatrix Biological Mesh MIROMATRIX MEDICAL INC. 510(k) NO: K160400(Special) ATTN: JEFF ROSS PHONE NO : 763 4588801 10399 WEST 70TH ST SE DECISION MADE: 08-JUN-16 Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: dynaMX(TM) Nitinol Compression Screw MX ORTHOPEDICS CORP. 510(k) NO: K160427(Traditional) ATTN: HOWARD L. SCHRAYER PHONE NO : 609 9249510 1050 WALTHAM STREET SE DECISION MADE: 03-JUN-16 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System Ascensia Diabetes Care US Inc. 510(k) NO: K160430(Special) ATTN: Jennifer L. Gregory PHONE NO : 574 2563447 430 South Beiger Street SE DECISION MADE: 24-JUN-16 Mishawaka IN 46544 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Identic and KromaFaze Alginate Dental Impression Materials KERR CORPORATION 510(k) NO: K160441(Traditional) ATTN: Mohammad Saad Ansari PHONE NO : 909 9625644 1717 W. COLLINS AVE. SE DECISION MADE: 30-JUN-16 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K160451(Traditional) ATTN: MELANIE AVILA PHONE NO : 210 5154059 6203 FARINON DRIVE SE DECISION MADE: 20-JUN-16 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BI IMAGE-X EVOLUTION RADIOTECNOLOGIA INDUSTRIAL S.A. DE510(k) NO: K160458(Traditional) ATTN: Marcelo Mojica PHONE NO : 01 800 6810538 CALLE PUEBLA SUR, MANZANA 4 LOTE 5SE DECISION MADE: 20-JUN-16 IXTAPALUCA MX 56535 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Synthetic Vinyl Examination Gloves, Powder-Free, Yellow INPRO TECHNOLOGY DEVICE FACTORY 510(k) NO: K160468(Traditional) ATTN: WANG YANMEI PHONE NO : 86 536 2197065 NO. 10-1, XING'AN ROAD EAST, LINQUSE DECISION MADE: 23-JUN-16 WEIFANG CN 262600 510(k) STATEMENT DEVICE: DSM Biomedical Porcine Pericardium Dental Membrane Kensey Nash Corporation dba DSM Bi510(k) NO: K160474(Traditional) ATTN: Brianna Schehr PHONE NO : 484 7132100 735 Pennsylvania Drive SE DECISION MADE: 07-JUN-16 Exton PA 19431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFY VH2O2 Indicator Tape STERIS CORPORATION 510(k) NO: K160485(Traditional) ATTN: Anthony Piotrkowski PHONE NO : 440 3927437 5960 HEISLEY ROAD SE DECISION MADE: 01-JUN-16 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reprocessed Inquiry Steerable Diagnostic EP Catheter Innovative Health, LLC. 510(k) NO: K160496(Traditional) ATTN: Rafal Chudzik PHONE NO : 480 5256006 1435 North Hayden Road, Suite 100 SE DECISION MADE: 10-JUN-16 Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dentivera Milling Disc Dental Solutions, LLC 510(k) NO: K160498(Traditional) ATTN: Kendra Shoulders PHONE NO : 770 7728649 7701 Golden Valley Road P.O.Box 27SE DECISION MADE: 15-JUN-16 Golden Valley MN 55427 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAKO 7 nVision Medical Corporation 510(k) NO: K160510(Traditional) ATTN: Surbhi Sarna PHONE NO : 408 6553577 2500 Grant Road, G01 SE DECISION MADE: 09-JUN-16 Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Naya Breast Pump System NAYA HEALTH INC. 510(k) NO: K160511(Traditional) ATTN: Janica B. Alvarez PHONE NO : 650 3466271 390 BRIDGE PKWY SUITE C SE DECISION MADE: 24-JUN-16 Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OptiCross 18, 30 MHz Peripheral Imaging Catheter BOSTON SCIENTIFIC CORPORATION 510(k) NO: K160514(Traditional) ATTN: Eric Elliott PHONE NO : 510 6241314 47215 LAKEVIEW BLVD SE DECISION MADE: 22-JUN-16 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BrightMatter Guide with BrightMatter Pointer SYNAPTIVE MEDICAL INC. 510(k) NO: K160523(Traditional) ATTN: Cameron Piron PHONE NO : 416 6736679 MARS CENTER, SOUTH TOWER, 101 COLLSE DECISION MADE: 24-JUN-16 TORONTO CA M5G 1L7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RCT700 RAY CO.,LTD 510(k) NO: K160525(Traditional) ATTN: Changhwan Lee PHONE NO : 82 31 6051000 332-7, SAMSUNG 1-RO SE DECISION MADE: 20-JUN-16 HWASEONG-SI KR 445-330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Masimo O3 Regional Oximeter System MASIMO CORPORATION 510(k) NO: K160526(Traditional) ATTN: MARGUERITE THOMLINSON PHONE NO : 949 2977683 52 DISCOVERY SE DECISION MADE: 09-JUN-16 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BiZact Open Sealer/Divider COVIDIEN 510(k) NO: K160539(Traditional) ATTN: Sharon McDermott PHONE NO : 303 5816789 5920 LONGBOW DR. SE DECISION MADE: 15-JUN-16 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM FLEXICARE MEDICAL LIMITED 510(k) NO: K160540(Third Party - Traditional) ATTN: JOEL BIDDLE PHONE NO : 44 144 3474560 CYNON VALLEY BUSINESS PARK SE DECISION MADE: 23-JUN-16 MOUNTAIN ASH GB CF45 4ER 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Withings Thermo (Model SCT01) WITHINGS 510(k) NO: K160544(Traditional) ATTN: Xavier Debreuil PHONE NO : 336 089 79794 20 Rue Maurice Hartmann SE DECISION MADE: 17-JUN-16 Issy-Les-Moulineaux FR 921300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M Attest Rapid Readout Biological Indicator 3M COMPANY 510(k) NO: K160546(Traditional) ATTN: Matt Mortensen PHONE NO : 651 7372670 3M CENTER, BUILDING 275-5W-06 SE DECISION MADE: 09-JUN-16 St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform EDWARDS LIFESCIENCES, LLC 510(k) NO: K160552(Traditional) ATTN: Tara Viviani PHONE NO : 949 2504030 ONE EDWARDS WAY SE DECISION MADE: 01-JUN-16 Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUEPRINT Patient Specific Instrumentation TORNIER SAS 510(k) NO: K160555(Special) ATTN: AYMEN AZAIEZ PHONE NO : 33 476 613500 161 RUE LAVOISIER SE DECISION MADE: 10-JUN-16 MONTBONNOT SAINT MARTIN FR 38330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FirstSense Breast Exam First Sense Medical, LLC 510(k) NO: K160573(Traditional) ATTN: Paul G. Angott PHONE NO : 248 3923006 2001 Centerpoint Parkways, Suite 1SE DECISION MADE: 01-JUN-16 Pontiac MI 48341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nustat XR Beeken Biomedical, LLC 510(k) NO: K160578(Traditional) ATTN: DAN O'HARA PHONE NO : 781 5524513 292-G Page Street SE DECISION MADE: 29-JUN-16 Stoughton MA 02072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surgical Navigation Advanced Platform (SNAP) SURGICAL THEATER, LLC 510(k) NO: K160584(Traditional) ATTN: Kevin Murrock PHONE NO : 330 4726520 781 BETA DR. SE DECISION MADE: 28-JUN-16 MAYFIELD VILLAGE OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aquilion ONE (TSX-305A/3) V7.3 Toshiba Medical Systems Corporatio510(k) NO: K160587(Traditional) ATTN: Paul Biggins PHONE NO : 714 6697808 1385 Shimoishigami SE DECISION MADE: 09-JUN-16 Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REBOA Balloon Catheter NUMED, INC. 510(k) NO: K160598(Traditional) ATTN: NICHELLE LAFLESH PHONE NO : 315 3284491 2880 MAIN STREET SE DECISION MADE: 20-JUN-16 HOPKINTON NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JustRight Surgical Vessel Sealing System JustRight Surgical 510(k) NO: K160602(Traditional) ATTN: Jenifer Kennedy PHONE NO : 720 2877130 357 S. Mcaslin Blvd Suite 120 SE DECISION MADE: 23-JUN-16 Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Large Screws Range NEWCLIP TECHNICS 510(k) NO: K160617(Traditional) ATTN: Gaelle LUSSORI PHONE NO : 33 2 28213712 PA de la Lande Saint Martin-45 rueSE DECISION MADE: 03-JUN-16 HAUTE-GOULAINE FR 44 115 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T GE MEDICAL SYSTEMS, LLC 510(k) NO: K160618(Special) ATTN: Jason Ma PHONE NO : 262 5484727 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 09-JUN-16 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Hot Biopsy Forceps MICRO-TECH (NANJING) CO., LTD. 510(k) NO: K160625(Traditional) ATTN: BECKY LI PHONE NO : 86 25 58646378 NO. 10 GAOKE THIRD ROAD SE DECISION MADE: 14-JUN-16 NANJING CN 210032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution QFIX 510(k) NO: K160627(Traditional) ATTN: Nadia Sookdeo Harhen PHONE NO : 610 2680585 440 CHURCH ROAD SE DECISION MADE: 14-JUN-16 AVONDALE PA 19311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lelo Hex Natural Rubber Latex Condom LELO Inc. 510(k) NO: K160644(Traditional) ATTN: Pavle Sedic PHONE NO : 408 2494000 4320 Stevens Creek Blvd., Suite 20SE DECISION MADE: 30-JUN-16 San Jose CA 95129 510(k) STATEMENT DEVICE: PreSep Oligon Oximetry Catheter EDWARDS LIFESCIENCES, LLC 510(k) NO: K160645(Traditional) ATTN: Deana Boushell PHONE NO : 949 7564472 1 EDWARDS WAY SE DECISION MADE: 16-JUN-16 IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: iFUSE Implant System SI-BONE, INC. 510(k) NO: K160652(Traditional) ATTN: ROXANNE DUBOIS PHONE NO : 408 2070700 2236 3055 OLIN AVENUE SUITE 2200 SE DECISION MADE: 03-JUN-16 SAN JOSE CA 95128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OrthoButton CL RIVERPOINT MEDICAL 510(k) NO: K160655(Traditional) ATTN: EDWIN ANDERSON PHONE NO : 503 5178001 825 NE 25TH AVENUE SE DECISION MADE: 03-JUN-16 PORTLAND OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HumaPen Savvio Eli Lilly and Company, Inc. 510(k) NO: K160668(Traditional) ATTN: Christine A. Phliips PHONE NO : 317 6256045 Lilly Corporate Center SE DECISION MADE: 03-JUN-16 Indianapolis IN 46285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ClariFix Device ARRINEX, INC. 510(k) NO: K160669(Traditional) ATTN: VAHID SAADAT PHONE NO : 408 8022052 1755 EAST BAYSHORE RD, STE 26 SE DECISION MADE: 24-JUN-16 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CenterCross Ultra Catheter ROXWOOD MEDICAL, INC 510(k) NO: K160681(Special) ATTN: Grace Li PHONE NO : 650 7794559 400 SEAPORT CT, SUITE 103 SE DECISION MADE: 17-JUN-16 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Acne Light Therapy Wand ZUKO, INC. 510(k) NO: K160691(Traditional) ATTN: Jay Tapper PHONE NO : 216 4709806 208 UPLAND WAY SE DECISION MADE: 21-JUN-16 Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Gibralt® Spine System and Gibralt® Occipital Spine System Exactech, Inc. 510(k) NO: K160697(Traditional) ATTN: Dawn Davisson PHONE NO : 352 3771140 2320 NW 66th Court SE DECISION MADE: 28-JUN-16 Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATTUNE Revision Knee System Depuy (Ireland) 510(k) NO: K160700(Traditional) ATTN: Jaime Weeks PHONE NO : 1 574 3727591 Loughbeg Ringaskiddy SE DECISION MADE: 10-JUN-16 Co. Cork Munster IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NeuroStar TMS Therapy System NEURONETICS, INC. 510(k) NO: K160703(Traditional) ATTN: Judy P. Ways PHONE NO : 610 6404202 3222 PHOENIXVILLE PIKE SE DECISION MADE: 10-JUN-16 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ally Warming Liquid Personal Lubricant GUY & O'NEILL, INC. 510(k) NO: K160717(Traditional) ATTN: THOMAS MISGEN PHONE NO : 262 6922469 200 INDUSTRIAL DRIVE SE DECISION MADE: 14-JUN-16 FREDONIA WI 53021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 Roche Diagnostics 510(k) NO: K160729(Traditional) ATTN: Adam Clark PHONE NO : 317 5214371 9115 Hague Road SE DECISION MADE: 13-JUN-16 Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZUK Select Knee System SMITH & NEPHEW, INC. 510(k) NO: K160738(Traditional) ATTN: BRAD SHEALS PHONE NO : 901 3996897 7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 15-JUN-16 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cranial COVER Neos Surgery S.L. 510(k) NO: K160739(Traditional) ATTN: Eduard Garcia PHONE NO : 34 935 944726 Parc Tecnologic del Valles, C/CeraSE DECISION MADE: 12-JUN-16 Cerdanyola del Valles ES 08290 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Symphion Endoscope and Symphion Cervical Sheath BOSTON SCIENTIFIC 510(k) NO: K160751(Traditional) ATTN: BROOKE CUDDY PHONE NO : 508 6836434 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 14-JUN-16 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length ETHICON ENDO-SUREGERY, LLC 510(k) NO: K160752(Traditional) ATTN: MARJORIE MEDINA PHONE NO : 787 6534603 475 CALLE C SE DECISION MADE: 29-JUN-16 GUAYNABO PR 00969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ally Liquid Personal Lubricant GUY & O'NEILL, INC. 510(k) NO: K160763(Traditional) ATTN: THOMAS MISGEN PHONE NO : 262 6922469 200 INDUSTRIAL DRIVE SE DECISION MADE: 29-JUN-16 FREDONIA WI 53021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vent-Os Sinus Dilation family SINUSYS CORPORATION 510(k) NO: K160770(Traditional) ATTN: Lloyd H. Griese PHONE NO : 650 2139988 2468 EMBARCADERO WAY SE DECISION MADE: 29-JUN-16 Palo Alto CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems CHOICE SPINE LP 510(k) NO: K160775(Traditional) ATTN: KIM FINCH PHONE NO : 865 2433969 400 Erin Drive SE DECISION MADE: 03-JUN-16 KNOXVILLE TN 37919 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: United Urologics Intermittent Catheter ROBLING MEDICAL 510(k) NO: K160795(Traditional) ATTN: Diane Peper PHONE NO : 919 5709605 90 WEATHERS STREET SE DECISION MADE: 16-JUN-16 YOUNGSVILLE NC 27596 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIO-P WAISMED LTD. 510(k) NO: K160805(Traditional) ATTN: Einat Swisa PHONE NO : 972 9 9517444 10 AMAL ST. AFEK INDUSTRIAL PARK, SE DECISION MADE: 23-JUN-16 Rosh Ha'Ayin IL 4809234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit THE BINDING SITE GROUP LTD. 510(k) NO: K160819(Traditional) ATTN: JON LAUDER PHONE NO : 44 121 4569500 8 CALTHORPE ROAD SE DECISION MADE: 16-JUN-16 EDGBASTON GB B15 1QT 510(k) STATEMENT DEVICE: PressON Pro Spinal Fixation System Nexus Spine, LLC 510(k) NO: K160820(Traditional) ATTN: Jared Crocker PHONE NO : 801 7028342 2825 E Cottonwood Parkway, Suite 3SE DECISION MADE: 28-JUN-16 Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tria Sapphire TRIA BEAUTY, INC. 510(k) NO: K160821(Traditional) ATTN: Heather Tanner PHONE NO : 925 4522500 4160 Dublin Blvd., Ste 200 SE DECISION MADE: 15-JUN-16 Dublin CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NC Quantum Apex PTCA Dilatation Catheter BOSTON SCIENTIFIC CORPORATION 510(k) NO: K160823(Special) ATTN: JANE HORAN PHONE NO : 763 4942572 ONE SCIMED PLACE SE DECISION MADE: 23-JUN-16 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 MERIDIAN BIOSCIENCE, INC. 510(k) NO: K160829(Traditional) ATTN: MICHELLE L. SMITH PHONE NO : 513 2713700 3471 RIVER HILLS DRIVE SE DECISION MADE: 13-JUN-16 CINCINNATI OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K160853(Traditional) ATTN: Flower Cai PHONE NO : 86 754 88250150 77 JINSHA ROAD SE DECISION MADE: 27-JUN-16 SHANTOU CN 515041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hospira Administration Sets HOSPIRA, INC. 510(k) NO: K160870(Special) ATTN: DAVID BLONSKI PHONE NO : 224 2125010 375 FIELD DRIVE SE DECISION MADE: 01-JUN-16 LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nanovis Intervertebral Body Fusion System and FortiCore® NANOVIS LLC 510(k) NO: K160874(Special) ATTN: Matthew Hedrick PHONE NO : 877 9076266 5865 E STATE RD. 14 SE DECISION MADE: 28-JUN-16 Columbia City IN 46725 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIS Metallic Stent Optimization E.4 SW LIGHTLAB IMAGING, INC. 510(k) NO: K160878(Traditional) ATTN: PADMINI SURAVARAM PHONE NO : 978 5773473 4 ROBBINS ROAD SE DECISION MADE: 29-JUN-16 WESTFORD MA 01866 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ultrathane Endoureterotomy Stent Set Cook Incorporated 510(k) NO: K160891(Traditional) ATTN: Kara Kanorr PHONE NO : 812 3392235 104072 750 Daniels Way SE DECISION MADE: 24-JUN-16 Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xpert Carba-R CEPHEID 510(k) NO: K160901(Traditional) ATTN: SCOTT A. CAMPBELL PHONE NO : 847 2283299 904 CARIBBEAN DRIVE SE DECISION MADE: 29-JUN-16 SUNNYVALE CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sonendo GentleWave System SONENDO, INC. 510(k) NO: K160905(Special) ATTN: DAN W. MILLER PHONE NO : 949 7663636 26061 MERIT CIRCLE, SUITE 102 SE DECISION MADE: 03-JUN-16 LAGUNA HILLS CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIDAS B.R.A.H.M.S. PCT (PCT) bioMerieux, Inc 510(k) NO: K160911(Traditional) ATTN: Thi My Lan Dang PHONE NO : 314 7318799 595 Anglum Rd. SE DECISION MADE: 28-JUN-16 Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CoRoent® Ti-C System NUVASIVE, INCORPORATED 510(k) NO: K160916(Traditional) ATTN: Michelle Cheung PHONE NO : 858 9093360 7475 LUSK BLVD SE DECISION MADE: 28-JUN-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: F1 MPS Modular Pedicle Screw System Degen Medical 510(k) NO: K160926(Traditional) ATTN: Craig Black PHONE NO : 843 9924551 1321-C North Cashua Drive SE DECISION MADE: 28-JUN-16 Florence SC 29501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aequalis PerFORM+ Shoulder System TORNIER, INC. 510(k) NO: K160975(Special) ATTN: Loucinda Bjorklund PHONE NO : 952 4267601 10801 Nesbitt Avenue South SE DECISION MADE: 10-JUN-16 Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive® Reline® System NuVasive, Incorporated 510(k) NO: K160989(Traditional) ATTN: Olga Lewis PHONE NO : 858 3205257 7475 Lusk Boulevard SE DECISION MADE: 09-JUN-16 San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOVIEW Plating System In2Bones SAS 510(k) NO: K160995(Traditional) ATTN: Morgane Grenier PHONE NO : 33 4 72292626 28 Chemin du Petit Bois SE DECISION MADE: 10-JUN-16 ECULLY FR 69130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILAGRO ADVANCE PEEK Interference Screw MEDOS INTERNATIONAL SARL 510(k) NO: K161001(Traditional) ATTN: Kristine Christo PHONE NO : CHEMIN-BLANC 38, CASE POSTALE SE DECISION MADE: 09-JUN-16 LE LOCLE CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector BOSTON SCIENTIFIC CORPORATION 510(k) NO: K161003(Traditional) ATTN: VIRGINIA GARCIA PHONE NO : 508 6834430 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 17-JUN-16 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape Canadian Technical Tape, Ltd. 510(k) NO: K161024(Special) ATTN: Howard Cohen PHONE NO : 800 3341567 455 Cote-Vertu Blvd SE DECISION MADE: 28-JUN-16 Montreal CA h4n 1E8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medline Singe Patient Use Blood Pressure Cuff MEDLINE INDUSTRIES, INC. 510(k) NO: K161035(Traditional) ATTN: Matt Clausen PHONE NO : 847 6434785 ONE MEDLINE PLACE SE DECISION MADE: 13-JUN-16 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) NeoMed, Inc. 510(k) NO: K161039(Traditional) ATTN: Tony Lair PHONE NO : 888 8762225 100 Londonderry Ct, Suite 112 SE DECISION MADE: 17-JUN-16 Woodstock GA 30188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Monoject Covidien 510(k) NO: K161045(Traditional) ATTN: Sona Manickam PHONE NO : 508 2618147 15 Hampshire Street SE DECISION MADE: 17-JUN-16 Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPAX Volume Viewing 4.0 AGFA HEALTHCARE N.V. 510(k) NO: K161061(Traditional) ATTN: Koen Cobbaert PHONE NO : 32 344 47539 SEPTESTRAAT 27 SE DECISION MADE: 22-JUN-16 MORTSEL BE B-2640 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NR Recorder Norav Medical GmbH 510(k) NO: K161062(Traditional) ATTN: David Seal PHONE NO : 49 0 6122705240 Otto von Guericke Ring 10 SE DECISION MADE: 13-JUN-16 Wiesbaden DE 65205 510(k) STATEMENT DEVICE: Penumbra System ACE 68 Reperfusion Catheter Penumbra, Inc. 510(k) NO: K161064(Special) ATTN: Charles DeNault PHONE NO : 510 7483302 One Penumbra Place SE DECISION MADE: 12-JUN-16 Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PolypVac Microdebrider (3.3mm and 4.0mm) LAURIMED LLC 510(k) NO: K161101(Special) ATTN: BRIAN R DUBOIS PHONE NO : 650 5875296 500 ARGUELLO ST., SUITE 100 SE DECISION MADE: 22-JUN-16 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sony IP Converter NU-IP40S SONY ELECTRONICS INC. 510(k) NO: K161122(Traditional) ATTN: AMARJIT 'ANDY' JOWANDHA PHONE NO : 201 7490810 1 SONY DRIVE SE DECISION MADE: 08-JUN-16 PARK RIDGE NJ 07656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator BOVIE MEDICAL CORPORATION 510(k) NO: K161134(Traditional) ATTN: BRIAN KUNST PHONE NO : 727 8038617 5115 ULMERTON ROAD SE DECISION MADE: 20-JUN-16 CLEARWATER FL 33760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Precision Treatment Planning System ACCURAY INCORPORATED 510(k) NO: K161136(Traditional) ATTN: Shweta Kaushik PHONE NO : 408 7164600 1310 CHESAPEAKE TERRACE SE DECISION MADE: 24-JUN-16 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: iDMS Data Management System ACCURAY INCORPORATED 510(k) NO: K161144(Traditional) ATTN: Elizabeth Osuna PHONE NO : 408 7164731 1310 CHESAPEAKE TERRACE SE DECISION MADE: 24-JUN-16 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Radixact Treatment Delivery System ACCURAY INCORPORATED 510(k) NO: K161146(Traditional) ATTN: Keith Picker PHONE NO : 608 8243069 1209 DEMING WAY SE DECISION MADE: 24-JUN-16 MADISON WI 53717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EndoCure Model EUR078A ENDOCURE TECHNOLOGIES, INC. 510(k) NO: K161147(Traditional) ATTN: CHARLES J. NEFF PHONE NO : 301 9378848 5801 AMMENDALE ROAD, SUITE A SE DECISION MADE: 07-JUN-16 BELTSVILLE MD 20705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO., LTD. 510(k) NO: K161156(Traditional) ATTN: SARAH SU PHONE NO : 886 282 271300 1201 9F, NO. 186, JIAN YI ROAD SE DECISION MADE: 14-JUN-16 ZHONGHE DISTRICT, NEW TAIPEI CITY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CareEvent inclusive of the CareEvent Mobile Application accessory PHILIPS MEDICAL SYSTEMS 510(k) NO: K161164(Traditional) ATTN: Theresa Poole PHONE NO : 978 6597621 3000 MINUTEMAN ROAD SE DECISION MADE: 24-JUN-16 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Oak Ridge Products Sharps Containers OAK RIDGE PRODUCTS, LLC 510(k) NO: K161180(Third Party - Traditional) ATTN: Tibor Kovari PHONE NO : 815 3634700 4612 Century Ct SE DECISION MADE: 09-JUN-16 McHenry IL 60050 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Halo One Thin-Walled Guiding Sheath C.R. BARD, INC 510(k) NO: K161183(Third Party - Traditional) ATTN: FIONA NI MHULLAIN PHONE NO : 353 53 9237111 MOYNE UPPER SE DECISION MADE: 03-JUN-16 ENNISCORTHY IE 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K161186(Special) ATTN: SHRADDHA MORE PHONE NO : 973 6862627 10 HIGH POINT DRIVE SE DECISION MADE: 29-JUN-16 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEPATIQ 1.1 HEPATIQ LLC 510(k) NO: K161188(Special) ATTN: DIPU GHOSH PHONE NO : 949 2501065 124 1150 Main Street, Suite E SE DECISION MADE: 09-JUN-16 Irvine CA 92614 510(k) STATEMENT DEVICE: Latera Absorbable Nasal Implant SPIROX, INC. 510(k) NO: K161191(Special) ATTN: Mike Rosenthal PHONE NO : 650 5033329 3475-O EDISON WAY SE DECISION MADE: 23-JUN-16 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 16ch Tx/Rx Knee SPEEDER Quality Electrodynamics, LLC 510(k) NO: K161193(Traditional) ATTN: Kathleen Aras PHONE NO : 440 4842964 700 Beta Drive Suite 100 SE DECISION MADE: 02-JUN-16 Mayfield Village OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K161214(Traditional) ATTN: Bin Chen PHONE NO : 86 20 32296069 WONDFO SCIENTECH PARK, SOUTH CHINASE DECISION MADE: 27-JUN-16 GUANGZHOU CN 510641 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Relizorb Alcresta Therapeutics, Inc. 510(k) NO: K161247(Traditional) ATTN: Robert Gallotto PHONE NO : 617 4313600 One Newton Executive Park, Suite 1SE DECISION MADE: 30-JUN-16 Newton MA 02462 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cervical Stand Alone System Orthofix Inc. 510(k) NO: K161280(Special) ATTN: Natalia Volosen PHONE NO : 214 9372145 3451 Plano Parkway SE DECISION MADE: 17-JUN-16 Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ablation Confirmation NEUWAVE MEDICAL, INC. 510(k) NO: K161285(Special) ATTN: DAN KOSEDNAR PHONE NO : 608 5121592 3529 ANDERSON STREET SE DECISION MADE: 29-JUN-16 MADISON WI 53704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Beta-2-Microglobulin Beckman Coulter Ireland Inc. 510(k) NO: K161297(Special) ATTN: Eimear Carr PHONE NO : 353 65 6831483 Lismeehan, O'Callaghan's Mills SE DECISION MADE: 07-JUN-16 Co. Clare IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CliniCloud Non-contact Thermometer, Model SPL1024 STETHOCLOUD PTY. LTD (CLINICLOUD) 510(k) NO: K161325(Third Party - Traditional) ATTN: ANDREW LIN PHONE NO : LEVEL 5, 141 FLINDERS LANE SE DECISION MADE: 22-JUN-16 MELBOURNE VIC AU 3000 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Sonic Window ANALOGIC CORPORATION 510(k) NO: K161342(Special) ATTN: MICHAEL J. DOYLE PHONE NO : 978 3264410 8 CENTENNIAL DRIVE SE DECISION MADE: 15-JUN-16 PEABODY MA 01960 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NormaTec PCD-T and PCD-B NormaTec Industries, LP 510(k) NO: K161346(Third Party - Traditional) ATTN: Peter Novello PHONE NO : 617 9283400 44 Glen Ave SE DECISION MADE: 15-JUN-16 Newton MA 02459 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ASAHI Corsair Armet Asahi Intecc Co., Ltd. 510(k) NO: K161362(Special) ATTN: Carroll Councilman PHONE NO : 949 7568252 1703 Wakita-cho, Moriyama-Ku SE DECISION MADE: 14-JUN-16 Nagoya JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arsenal Spinal Fixation System ALPHATEC SPINE, INC 510(k) NO: K161363(Special) ATTN: RENEE MURPHY PHONE NO : 760 4946739 5818 EL CAMINO REAL SE DECISION MADE: 10-JUN-16 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BinaxNOW G6PD Test ALERE SCARBOROUGH, INC. 510(k) NO: K161364(Special) ATTN: Angela Drysdale PHONE NO : 207 7305737 10 SOUTHGATE ROAD SE DECISION MADE: 17-JUN-16 Scarborough ME 04074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) CONFORMIS, INC. 510(k) NO: K161366(Special) ATTN: AMITA SHAH PHONE NO : 781 3459164 28 Crosby Dr. SE DECISION MADE: 14-JUN-16 Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Single Use Surgical Suction Irrigator JIANGSU HAIZE MEDICAL SCIENTIFIC D510(k) NO: K161421(Traditional) ATTN: Vivian Sun PHONE NO : 086 0510 82832301 NO.99, FURONGZHONGSAN RD, XISHAN ESE DECISION MADE: 24-JUN-16 WUXI CN 214000 510(k) STATEMENT DEVICE: Target Detachable Coils Stryker Neurovascular 510(k) NO: K161429(Special) ATTN: Kate Taylor PHONE NO : 510 4132175 47900 Bayside Parkway SE DECISION MADE: 22-JUN-16 Fremont CA 94538-2588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBSWIN and VistaEasy Imaging Software Duerr Dental AG 510(k) NO: K161444(Special) ATTN: Oliver Lange PHONE NO : 49 07142 7050 Hoepfigheimer Str. 17 SE DECISION MADE: 21-JUN-16 Bietigheim-Bissingen DE D-74321 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMR Shoulder System Limacorporate S.p.A. 510(k) NO: K161476(Special) ATTN: Sara Viel PHONE NO : 39 043 2945511 Via Nazionale, 52 Villanova di SanSE DECISION MADE: 24-JUN-16 Udine IT 33038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: hipEOS ONEFIT MEDICAL 510(k) NO: K161479(Special) ATTN: Julien SIMON PHONE NO : 33 038 1252427 18 RUE ALAIN SAVARY SE DECISION MADE: 28-JUN-16 BESANCON FR 25000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EndoChoice Water Bottle Cap Irrigation System ENDOCHOICE, INC. 510(k) NO: K161482(Special) ATTN: DAINEL HOEFER PHONE NO : 678 7084743 11810 WILLS RD. SE DECISION MADE: 27-JUN-16 ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) LUMINEX CORPORATION 510(k) NO: K161495(Special) ATTN: CHRISTIE HUGHES PHONE NO : 512 2198020 12212 TECHNOLOGY BLVD. SE DECISION MADE: 30-JUN-16 AUSTIN TX 78727 510(k) STATEMENT DEVICE: LIAISON EBV IgM Serum Control Set DiaSorin Inc. 510(k) NO: K161522(Special) ATTN: John Walter PHONE NO : 651 4399710 1951 Northwestern Ave. P.O. Box 28SE DECISION MADE: 30-JUN-16 Stillwater MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON CMV IgM Serum Control Set DiaSorin Inc. 510(k) NO: K161526(Special) ATTN: JOHN WALTER PHONE NO : 651 4399710 1951 Northwestern Avenue SE DECISION MADE: 30-JUN-16 Stillwater MN 555082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arthrosurface Bone Screws ARTHROSURFACE, INC. 510(k) NO: K161539(Special) ATTN: DAWN J. WILSON PHONE NO : 508 5203003 28 FORGE PARKWAY SE DECISION MADE: 30-JUN-16 FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit Centers for Disease Control and Pr510(k) NO: K161556(Special) ATTN: Yon Yu PHONE NO : 404 6393046 1600 Clifton, MS-C18 SE DECISION MADE: 30-JUN-16 Atlanta GA 30329-4027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Kuvia3D 4QIMAGING, LLC DBA QMETRICS 510(k) NO: K161559(Traditional) ATTN: EDWARD SCHREYER PHONE NO : 585 3014300 1250 PITTSFORD-VICTOR RD., SUITE SE DECISION MADE: 23-JUN-16 PITTSFORD NY 14534 510(k) SUMMARY AVAILABLE FROM FDA
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