510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2016
TOTAL 510(k)s THIS PERIOD 236 TOTAL WITH SUMMARIES 220 TOTAL WITH STATEMENTS 16
DEVICE: Dakin's Skin and Wound Cleanser CENTURY PHARMACEUTICALS, INC. 510(k) NO: K150208(Traditional) ATTN: Stephen Deardorff PHONE NO : 1 317 8494210 10377 HAGUE RD. SE DECISION MADE: 21-JUL-16 INDIANAPOLIS IN 46256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sheath Introducer BIOTEQUE CORP. 510(k) NO: K150932(Traditional) ATTN: Simon Lin PHONE NO : 886 2 25710269 5 F-6, NO. 23, SEC. 1 CHANG-AN E. SE DECISION MADE: 22-JUL-16 TAIPEI TW 104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: The Progressive Orthopaedic Total Hip System The Progressive Orthopaedic Compan510(k) NO: K151424(Traditional) ATTN: Scott Keiser PHONE NO : 561 4404460 801 US Highway 1, Suite B SE DECISION MADE: 27-JUL-16 North Palm Beach FL 33408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ET III Bio-SA Fixture System HiOSSEN Inc. 510(k) NO: K151626(Traditional) ATTN: David Kim PHONE NO : 267 759 7031 85 Ben Fairless Dr. SE DECISION MADE: 21-JUL-16 Fairless Hills PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMT Platinum Depthalon Depth Electrode PMT CORPORATION 510(k) NO: K151790(Traditional) ATTN: KIM SCHMELZER PHONE NO : 1 952 4700866 1500 PARK RD SE DECISION MADE: 14-JUL-16 CHANHASSEN MN 55317 510(k) STATEMENT DEVICE: BD U-500 INSULIN SYRINGE BECTON, DICKINSON AND COMPANY 510(k) NO: K151870(Traditional) ATTN: LUISA F. METRIO PHONE NO : 201 8474739 1 BECTON DRIVE SE DECISION MADE: 08-JUL-16 FRANKLIN LAKES NJ 07666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control EDAN INSTRUMENTS, INC. 510(k) NO: K151978(Traditional) ATTN: TRACY YUE PHONE NO : 86 755 26856469 3/F-B, NANSHAN MEDICAL EQUIPMENTS SE DECISION MADE: 15-JUL-16 SHENZHEN CN 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HeatLux Pro II HOME SKINOVATIONS LTD. 510(k) NO: K152087(Traditional) ATTN: Ahava Stein PHONE NO : 972 4 9097470 Tabor Building, Shaar Yokneam SE DECISION MADE: 29-JUL-16 Yoqneam Iillit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Genesys Spine Apache® Anchored Cervical Interbody Fusion System GENESYS SPINE 510(k) NO: K152099(Traditional) ATTN: BEN KELLER PHONE NO : 512 3817073 1250 CAPITAL OF TEXAS HWY BUILDINGSE DECISION MADE: 28-JUL-16 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BioHPP - breCAM.BioHPP Bredent GmbH & Co.KG 510(k) NO: K152113(Traditional) ATTN: Stefanie Bochtler PHONE NO : 49 07309 8720 Weissenhorner Strasse 2 SE DECISION MADE: 21-JUL-16 Senden DE 89250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JSM Insulin Pen Needle JEESUNG MEDICAL CO LTD 510(k) NO: K152166(Traditional) ATTN: CHOI YONG HYUN PHONE NO : 82 42 9326061 54, MUJINI 1-GIL, DAEDEOK-GU SE DECISION MADE: 11-JUL-16 DAEJEON KR 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOTECH ECR Advanced Sterilization Products (A510(k) NO: K152189(Traditional) ATTN: Nazanin Yacobi PHONE NO : 949 7898672 33 Technology Dr SE DECISION MADE: 20-JUL-16 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FDR Visionary Suite SHIMADZU CORPORATION 510(k) NO: K152294(Traditional) ATTN: TOSHIO KADOWAKI PHONE NO : 81 75 8231305 1 NISHINOKYO-KUWABARACHO NAKAGYO-KSE DECISION MADE: 15-JUL-16 KYOTO JP 604-8511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Zeramex P6 Dental Implant System DENTALPOINT AG 510(k) NO: K152385(Traditional) ATTN: Viktor Lienhard PHONE NO : 41 443 883636 Hohlstrasse 614 SE DECISION MADE: 27-JUL-16 Zurich CH 8048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: The Time Machine Series Lasers MEDICAL LASERS MANUFACTURER INC. 510(k) NO: K152461(Traditional) ATTN: BRUCE SCHOENGOOD PHONE NO : 732 7868044 4400 ROUTE 9 SOUTH, SUITE 1000 SE DECISION MADE: 08-JUL-16 FREEHOLD NJ 07728 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula PROSURG, INC 510(k) NO: K152511(Traditional) ATTN: ASHVIN DESAI PHONE NO : 408 9454044 2193 TRADE ZONE BLVD SE DECISION MADE: 11-JUL-16 SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Gemini Sterilization Wrap MEDLINE INDUSTRIES, INC. 510(k) NO: K152564(Traditional) ATTN: Jennifer Mason PHONE NO : 847 6433652 ONE MEDLINE PLACE SE DECISION MADE: 07-JUL-16 MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System OK BIOTECH CO., LTD. 510(k) NO: K152599(Traditional) ATTN: KE-MIN JEN PHONE NO : 886 3 5160258 NO. 91, SEC. 2, GONGDAO 5TH ROAD SE DECISION MADE: 20-JUL-16 HSINCHU CITY TW 30070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Alta ACDF System BIOMET SPINE 510(k) NO: K152622(Traditional) ATTN: ALEXANDRA BECK PHONE NO : 303 5018397 310 INTERLOCKEN PARKWAY, SUITE 120SE DECISION MADE: 08-JUL-16 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pulse H20h! TOASTER LABS, INC 510(k) NO: K152628(Traditional) ATTN: AMY C. BUCKALTER PHONE NO : 206 9108332 2212 QUEEN ANNE AVENUE NORTH, #269SE DECISION MADE: 11-JUL-16 SEATTLE WA 98109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pulse Aloe-ahh TOASTER LABS, INC 510(k) NO: K152671(Traditional) ATTN: AMY C. BUCKALTER PHONE NO : 206 9108332 2212 QUEEN ANNE AVENUE NORTH, #269SE DECISION MADE: 11-JUL-16 SEATTLE WA 98109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PlasmaBlade TnA Tonsil and Adenoid Dissection Device MEDTRONIC ADVANCED ENERGY 510(k) NO: K152703(Traditional) ATTN: LYDIA SAKAKEENY PHONE NO : 603 2945482 180 INTERNATIONAL DRIVE SE DECISION MADE: 08-JUL-16 PORTSMOUTH NH 03801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XP1100 RF BTL INDUSTRIES, INC 510(k) NO: K152731(Traditional) ATTN: JAN ZARSKY PHONE NO : 866 2851656 47 Loring Drive SE DECISION MADE: 20-JUL-16 Framingham MA 01702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH GPS BLUE ORTHO 510(k) NO: K152764(Traditional) ATTN: ANTHONY BOYER PHONE NO : 33 476 549546 5 AVENUE DU GRAND SABLON SE DECISION MADE: 13-JUL-16 LA TRONCHE FR 38700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ST Internal Fixture System T-PLUS IMPLANT TECH. CO., LTD. 510(k) NO: K152787(Traditional) ATTN: DANA CHENG PHONE NO : 866 2 22981950 NO. 41, WUQUAN 6TH RD.. WUGU DIST.SE DECISION MADE: 22-JUL-16 NEW TAIPEI CITY TW 24889 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE SUNG SHIM MEDICARE CO., LTD. 510(k) NO: K152803(Traditional) ATTN: KIM YOUNG KWAN PHONE NO : 82 326 767066 190, MAESIL-RO SOJEONG-MYEON SE DECISION MADE: 12-JUL-16 SEJONG-SI KR 30002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer ARC DEVICES LIMITED 510(k) NO: K152905(Traditional) ATTN: GARY BROGAN PHONE NO : 353 91 653155 2 DEERPARK INDUSTRIAL ESTATE, ORANSE DECISION MADE: 20-JUL-16 GALWAY IE H91 D72H 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle CREGANNA MEDICAL ASLO BUSINESS AS 510(k) NO: K152913(Traditional) ATTN: ORLA HICKEY PHONE NO : 353 91 783469 PARKMORE WEST SE DECISION MADE: 21-JUL-16 GALWAY IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Savannah-T® Pedicle Screw System AMENDIA, INC. 510(k) NO: K152920(Traditional) ATTN: KRISTEN ALLEN PHONE NO : 877 7553329 1755 WEST OAK PARKWAY SE DECISION MADE: 08-JUL-16 MARIETTA GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-Cath PAJUNK GmbH Medizintechnologie 510(k) NO: K152952(Traditional) ATTN: Christian G.H. Quass PHONE NO : 49 077 049291586 Karl-Hall-Str. 1 SE DECISION MADE: 13-JUL-16 Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELAN 4 Motor System AESCULAP, INC. 510(k) NO: K152960(Traditional) ATTN: PETER STOLL PHONE NO : 610 7979300 3773 CORPORATE PARKWAY SE DECISION MADE: 22-JUL-16 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hudson RCI AquaPak Sterile Prefilled Nebulizers Teleflex Medical, Inc. 510(k) NO: K153010(Traditional) ATTN: Brian Gall PHONE NO : 919 5448000 682514 3015 Carrington Mill Blvd SE DECISION MADE: 26-JUL-16 Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Voyant Fine Fusion APPLIED MEDICAL RESOURCES 510(k) NO: K153017(Traditional) ATTN: JESSICA CHO PHONE NO : 949 7137958 22872 AVENIDA EMPRESA SE DECISION MADE: 06-JUL-16 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AcceleDent Aura ORTHOACCEL TECHNOLOGIES, INC. 510(k) NO: K153048(Traditional) ATTN: Zaffer Syed PHONE NO : 832 8030339 6575 WEST LOOP SOUTH, SUITE 200 SE DECISION MADE: 08-JUL-16 BELLAIRE TX 77401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE Electrosurgical Resection and Vaporization Electrodes Series Ace Medical Devices Pvt. Ltd. 510(k) NO: K153055(Traditional) ATTN: Vikas Sethi PHONE NO : 91 20 26681483 E-1/7, Neptune Society Kalyani NagSE DECISION MADE: 11-JUL-16 Pune IN 411006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress SYBRON DENTAL SPECIALTIES 510(k) NO: K153067(Traditional) ATTN: Courtney Clark PHONE NO : 714 5167634 1717 W. COLLINS AVENUE SE DECISION MADE: 27-JUL-16 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Watch-PAT200U ITAMAR MEDICAL, LTD. 510(k) NO: K153070(Traditional) ATTN: KOBY SHEFFY PHONE NO : 972 4 6177000 9 HALAMISH ST. SE DECISION MADE: 26-JUL-16 CAESAREA IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal COVIDIEN 510(k) NO: K153074(Traditional) ATTN: Karin Desjardins PHONE NO : 508 4521856 15 HAMPSHIRE STREET SE DECISION MADE: 06-JUL-16 MANSFILED MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved Ivy Sports Medicine, LLC 510(k) NO: K153087(Traditional) ATTN: John Dichiara PHONE NO : 650 5620800 545 Penobscot Drive SE DECISION MADE: 14-JUL-16 Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Belvedere™ Lateral Plating System NEUROSTRUCTURES, INC. 510(k) NO: K153097(Traditional) ATTN: Moti Altarac PHONE NO : 800 3526103 16 TECHNOLOGY DR. SUITE 165 SE DECISION MADE: 15-JUL-16 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MLX™ - Medial Lateral Expandable Lumbar Interbody System NuVasive, Incorporated 510(k) NO: K153105(Traditional) ATTN: Olga Lewis PHONE NO : 858 3205257 7475 Lusk Blvd. SE DECISION MADE: 11-JUL-16 San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM AESKU. SYSTEMS GMBH & CO. KG 510(k) NO: K153117(Traditional) ATTN: TOM STECKLUM PHONE NO : 49 6734 96220 MIKROFORUM RING 3 SE DECISION MADE: 28-JUL-16 WENDELSHEIM DE 55234 510(k) STATEMENT DEVICE: DuraLazeTM HoLEP Laser Fiber MedKey, LLC 510(k) NO: K153124(Traditional) ATTN: Jeff Zerfas PHONE NO : 812 3459946 2620 N. Walnut Street, SUite 1205 SE DECISION MADE: 26-JUL-16 Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls INSTRUMENTATION LABORATORY CO. 510(k) NO: K153137(Traditional) ATTN: Carol Marble PHONE NO : 718 8614467 180 HARTWELL Road SE DECISION MADE: 08-JUL-16 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lumipulse G TP-N Immunoreaction Cartridge Set Fujirebio Diagnostics, Inc. 510(k) NO: K153145(Traditional) ATTN: Diana Dickson PHONE NO : 610 2403917 201 Great Valley Parkway SE DECISION MADE: 05-JUL-16 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ShefaBone SCPC Resorbable Bone Graft THE IMPLANTECH INC./SHEFABONE 510(k) NO: K153230(Traditional) ATTN: AHMED EL-GHANNAM PHONE NO : 704 6877730 9016 CLIFF CAMERON DR., #201 SE DECISION MADE: 14-JUL-16 CHARLOTTE NC 28269 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer GC AMERICA, INC. 510(k) NO: K153231(Traditional) ATTN: Mark Heiss PHONE NO : 708 5970900 3737 W. 127TH ST. SE DECISION MADE: 06-JUL-16 ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AirLife Adult Heated Wire Circuit CAREFUSION INC 510(k) NO: K153234(Traditional) ATTN: ERIKA FERNANDEZ PHONE NO : 847 3628097 75 N FAIRWAY DRIVE SE DECISION MADE: 07-JUL-16 VERNON HILLS IL 600601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Styrker OrthoMap Express Knee System STRYKER CORPORATE 510(k) NO: K153240(Traditional) ATTN: Becky Ditty PHONE NO : 269 3893434 BOETZINGER STR. 41 SE DECISION MADE: 07-JUL-16 FREIBURG, BADEN-WUERTTEMBERG DE 7510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash ORIGIO A/S 510(k) NO: K153267(Traditional) ATTN: Tove Kjaer PHONE NO : 45 467 90220 KNARDRUPVEJ 2 SE DECISION MADE: 22-JUL-16 MALOV DK 2760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NR Line Implant System DENTIUM CO., LTD. 510(k) NO: K153268(Traditional) ATTN: YOUNJUNG YUK PHONE NO : 82 250 18560 29 TEHERAN-RO, 87-GZL GANGNAM-GU SE DECISION MADE: 20-JUL-16 SEOUL KP 06167 510(k) STATEMENT DEVICE: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set RELIEVANT MEDSYSTEMS 510(k) NO: K153272(Traditional) ATTN: ADAM SAVAKUS PHONE NO : 650 3681000 2688 MIDDLEFIELD ROAD, SUITE A SE DECISION MADE: 09-JUL-16 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDINAUT Kyphoplasty System IMEDICOM Co., Ltd. 510(k) NO: K153296(Traditional) ATTN: Bonggu Ha PHONE NO : 82 31 4791156 #612, 172, LS-ro SE DECISION MADE: 29-JUL-16 Gunpo-si KR 435-824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Gradia Plus GC America Inc. 510(k) NO: K153325(Traditional) ATTN: Mark Heiss PHONE NO : 708 9263090 3737 W. 127th Street SE DECISION MADE: 12-JUL-16 Alsip IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUNCO Mechanical Wheelchair, model SKW-9003 DANYANG SUNCO MACHINERY CO., LTD 510(k) NO: K153328(Traditional) ATTN: JEN KE-MIN PHONE NO : 86 511 86733686 TAOJING ROAD, OPTICS INDUSTRIAL PASE DECISION MADE: 20-JUL-16 DANYANG CITY CN 212300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: i-STAT Alinity System with i-STAT Sodium test ABBOTT POINT OF CARE INC. 510(k) NO: K153357(Traditional) ATTN: MELISSA ROBINSON PHONE NO : 609 4549371 400 COLLEGE ROAD EAST SE DECISION MADE: 08-JUL-16 PRINCETON NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Red2Green Reusable Sharps Container TRIUMVIRATE ENVIRONMENTAL, INC. 510(k) NO: K153363(Traditional) ATTN: STEVE TODISCO PHONE NO : 888 8349697 200 INNER BELT ROAD SE DECISION MADE: 26-JUL-16 Somerville MA 02143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LightStim Professional LED Bed LED Intellectual Properties LLC 510(k) NO: K153399(Traditional) ATTN: Steve Marchese PHONE NO : 949 5024088 16552 Von Karman Ave SE DECISION MADE: 05-JUL-16 Irvine CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Panpac Disposable Pessary Fitting Set Panpac Medical Corporation 510(k) NO: K153422(Special) ATTN: YEN-MING PAN PHONE NO : 886 2 86472242 6F-1,2, NO. 202, SEC.3 TA-TONG ROASE DECISION MADE: 14-JUL-16 SHI-CHIH DISTRICT TW 22103 510(k) STATEMENT DEVICE: PathLoc-C Posterior Cervical Fixation System L&K BIOMED CO., LTD. 510(k) NO: K153439(Traditional) ATTN: Yerim An PHONE NO : 82 267 171985 #201, 202 16-25, DONGBAEKJUNGANG-RSE DECISION MADE: 21-JUL-16 Giheung-gu, Yongin-si KR 446-916 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Braemar Telemetry Patch System Braemar Manufacturing, LLC 510(k) NO: K153473(Special) ATTN: Kent Sayler PHONE NO : 619 2437500 3890 Murphy Canyon Road, Suite 100SE DECISION MADE: 22-JUL-16 San Diego CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dillard Airway Dilatation System INTUIT MEDICAL PRODUCTS, LLC 510(k) NO: K153484(Traditional) ATTN: JACK GRIFFIS PHONE NO : 404 5836889 6018 EAGLES REST TRAIL SE DECISION MADE: 27-JUL-16 SUGAR HILL GA 30518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Clip Flow VOCO GmbH 510(k) NO: K153493(Traditional) ATTN: M. Th. Plaumann PHONE NO : 49 4721 7190 Anton-Flettner-Str. 1-3 SE DECISION MADE: 29-JUL-16 Cuxhaven DE 27472 510(k) STATEMENT DEVICE: Operio TOUL MEDITECH AB 510(k) NO: K153498(Traditional) ATTN: Tomas Hansson PHONE NO : 46 21 135000 TUNBYTORPSGATAN 31 SE DECISION MADE: 20-JUL-16 Västerås SE 72137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tearaway Introducer Sheath, MicroSlide Tearaway Introducer GALT MEDICAL CORP. 510(k) NO: K153533(Traditional) ATTN: DAVID DERRICK PHONE NO : 972 2715177 2220 MERRITT DR. SE DECISION MADE: 05-JUL-16 GARLAND TX 75041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System IQuum, Inc. 510(k) NO: K153544(Dual Track) ATTN: Lingjun Chen PHONE NO : 508 2293203 700 Nickerson Road SE DECISION MADE: 25-JUL-16 Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABPM 7100, Hypertension Management Software I.E.M. GMBH 510(k) NO: K153557(Traditional) ATTN: Hella Witt PHONE NO : 49 2402 95000 COCKERILLSTR. 69 SE DECISION MADE: 19-JUL-16 Stolberg DE 52222 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: InMode Plus System InMode MD Ltd. 510(k) NO: K153568(Traditional) ATTN: Ahava Stein PHONE NO : 972 49096307 Tabor Building, Shaar Yokneam, POBSE DECISION MADE: 12-JUL-16 Yoqneam IL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Juliet® Ti SPINEART 510(k) NO: K153621(Traditional) ATTN: FRANCK PENNESI PHONE NO : 41 22 5701246 INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 15-JUL-16 Geneva CH 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sorbact Foam Gentle Border, Sorbact Superabsorbent ABIGO Medical AB 510(k) NO: K153674(Traditional) ATTN: Annica Corbe PHONE NO : 0046 317 484950 Ekonomivagen 5 SE DECISION MADE: 01-JUL-16 Askim SE SE-43633 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K153700(Traditional) ATTN: Paul Amudala PHONE NO : 610 9849303 3773 Corporate Parkway SE DECISION MADE: 08-JUL-16 Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAcel Premium Fractional RF Micro Needle (FRM) System JEISYS MEDICAL, INC. 510(k) NO: K153727(Traditional) ATTN: HYOSEOK LEE PHONE NO : 82 226 036417 307 Daeryung Techno Town 8th, GamaSE DECISION MADE: 21-JUL-16 SEOUL KR 153-775 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder Free Blue Nitrile Examination Glove QUBE MEDICAL PRODUCT SDN BHD 510(k) NO: K153732(Traditional) ATTN: TEO SIONG YAM PHONE NO : 06 03 60345857 NO. 9, JALAN KPK 1/1, KAWASAN PERISE DECISION MADE: 29-JUL-16 RAWANG MY 48020 510(k) STATEMENT DEVICE: PROW FUSION-V NLT SPINE LTD 510(k) NO: K153786(Traditional) ATTN: Eti Zinger PHONE NO : 972 3 6344514 6 YAD HARUTZIM ST. SE DECISION MADE: 11-JUL-16 KFAR-SABA IL 4464103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Steth IO STRATOSCIENTIFIC, INC. 510(k) NO: K160016(Traditional) ATTN: SUMAN MULUMUDI PHONE NO : 425 8764310 1574 NORTHWEST 190TH STREET SE DECISION MADE: 15-JUL-16 SHORELINE WA 98177 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) SUNRISE MEDICAL (US) LLC 510(k) NO: K160031(Traditional) ATTN: LAURIE H ROBERTS PHONE NO : 559 3482572 2842 BUSINESS PARK AV SE DECISION MADE: 14-JUL-16 FRESNO CA 93727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UniStrip1 Generic Blood Glucose Test Strips OK BIOTECH CO., LTD. 510(k) NO: K160038(Traditional) ATTN: KE-MIN JEN PHONE NO : 886 3 5160258 NO. 91, SEC. 2, GONGDAO 5TH ROAD SE DECISION MADE: 29-JUL-16 HSINCHU CITY TW 30070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: t:slim Insulin Delivery System Tandem Diabetes Care, Inc. 510(k) NO: K160056(Traditional) ATTN: Michael Sarrasin PHONE NO : 858 3666900 11045 Roselle Street SE DECISION MADE: 25-JUL-16 San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set JBW7 Innovations, LLC 510(k) NO: K160077(Traditional) ATTN: Jason B Wynberg PHONE NO : 248 996 2775 22200 W. 11 Mile Road, # 4182 SE DECISION MADE: 12-JUL-16 Southfield MI 48037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Puritan Opti-Tranz Cary-Blair Collection and Transport System PURITAN MEDICAL PRODUCTS LLC 510(k) NO: K160082(Traditional) ATTN: MEHDI KARAMCHI PHONE NO : 207 8763311 3284 31 SCHOOL STREET P.O. BOX 149 SE DECISION MADE: 29-JUL-16 GUILFORD ME 04443-0149 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHOFU Enamel Conditioner SHOFU DENTAL CORPORATION 510(k) NO: K160086(Traditional) ATTN: MAURO MALZYNER PHONE NO : 760 7363277 1225 STONE DRIVE SE DECISION MADE: 21-JUL-16 SAN MARCOS CA 92078 510(k) STATEMENT DEVICE: Cydar EV Cydar Ltd. 510(k) NO: K160088(Traditional) ATTN: John Clarke PHONE NO : 44 1223 778020 Bulbeck Mill, Mill Lane SE DECISION MADE: 07-JUL-16 Barrington GB CB22 7QY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SinuBand BIOINSPIRE TECHNOLOGIES, INCORPORA510(k) NO: K160101(Traditional) ATTN: DORNA HAKIMIMEHR PHONE NO : 707 2395707 2450 EMBARCADERO WAY SE DECISION MADE: 27-JUL-16 PALO ALTO CA 94303-3313 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Amber Mill Series and Amber Press Series HASS CORP. 510(k) NO: K160102(Traditional) ATTN: YONGSU KIM PHONE NO : 82 70 77121300 77-14, GWAHAKDANJI-RO SE DECISION MADE: 14-JUL-16 GANGNEUNG-SI KR 210-340 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DiamondTOUCH Inflation Device and Fluid Dispensing Syringe Merit Medical Systems, Inc. 510(k) NO: K160107(Traditional) ATTN: Dan W Lindsay PHONE NO : 801 2084408 1600 West Merit Parkway SE DECISION MADE: 29-JUL-16 South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Apinator Allen J. Moses, DDS LTD 510(k) NO: K160123(Abbreviated) ATTN: Allen J Moses PHONE NO : 312 9930430 233 S. Wacker Drive SE DECISION MADE: 12-JUL-16 Chicago IL 60606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: rainbow LS Block GENOSS CO., LTD. 510(k) NO: K160144(Traditional) ATTN: HAN YEIN PHONE NO : 82 31 8885100 1F GYEONGGI R&DB CENTER, 105 GWANGSE DECISION MADE: 21-JUL-16 SUWON-SI KR 16229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NobelProcera HT ML FCZ Implant Bridge and Framework Nobel Biocare AB 510(k) NO: K160158(Traditional) ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830 BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 25-JUL-16 Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Atteris Antimicrobial Skin & Wound Cleanser ROCHAL INDUSTRIES LLC 510(k) NO: K160192(Traditional) ATTN: WILLIAM J. COULSTON PHONE NO : 210 8706534 12719 CRANES MILL SE DECISION MADE: 28-JUL-16 SAN ANTONIO TX 78230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Polux , Minerva and Atropos PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd. 510(k) NO: K160256(Traditional) ATTN: Tina Yin PHONE NO : 86 769 22892018 15th Bldg., SMEs Venture Park, SonSE DECISION MADE: 29-JUL-16 Dongguan CN 523808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 SAN-M PACKAGE CO., LTD. 510(k) NO: K160271(Abbreviated) ATTN: Shogo Nagao PHONE NO : 81 547 454125 1086-1 OJIRO SE DECISION MADE: 15-JUL-16 SHIMADA-CITY JP 428-8652 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) Fudakang Industrial Co., Ltd 510(k) NO: K160308(Special) ATTN: Bob Yu PHONE NO : 86 769 81098181 No. 8 Yinghe Road, Yuanjiangyuan MSE DECISION MADE: 15-JUL-16 Dongguan CN 523560 510(k) STATEMENT DEVICE: Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider SURGICAL INSTRUMENT SERVICE AND SA510(k) NO: K160333(Traditional) ATTN: BRANDI J. PANTELEON PHONE NO : 541 9233310 2747 SW 6TH ST. SE DECISION MADE: 20-JUL-16 REDMOND OR 97756 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cardinal Health Isolation Gown Cardinal Health 200, LLC 510(k) NO: K160339(Traditional) ATTN: Caroline Miceli PHONE NO : 847 8876864 1500 Waukegan Road SE DECISION MADE: 28-JUL-16 Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Nissin-Metec China Co., Ltd. 510(k) NO: K160367(Traditional) ATTN: Xiwei Shen PHONE NO : 86 512 36857051 No. 883 Beimen Road, Yushan Town SE DECISION MADE: 27-JUL-16 Kunshan CN 215316 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URITEK TC-201 URINE CHEMISTRY TEST SYSTEM TECO DIAGNOSTICS, INC. 510(k) NO: K160372(Traditional) ATTN: AQUIL MERCHANT PHONE NO : 714 4631111 1268 N. LAKEVIEW AVE. SE DECISION MADE: 22-JUL-16 ANAHEIM CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Precision Screw CRYPTYCH PTY LTD 510(k) NO: K160385(Traditional) ATTN: GREG ROGER PHONE NO : 61 414 899799 SUITE 106, 275 ALFRED STREET SE DECISION MADE: 27-JUL-16 North Sydney AU 2060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Skyn Original Polyisoprene Lubricated Male Condom Ansell Healthcare Products, LLC 510(k) NO: K160399(Abbreviated) ATTN: Robert Mahler PHONE NO : 732 3452174 111 Wood Avenue South, Suite 210 SE DECISION MADE: 25-JUL-16 Iselin NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating CARDINAL HEALTH, INC. 510(k) NO: K160411(Traditional) ATTN: Megan Middaugh PHONE NO : 847 8876812 1500 WAUKEGAN ROAD SE DECISION MADE: 25-JUL-16 WAUKEGAN IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAD/CAMouflage Milling Bock Prismatik Dentalcraft, Inc. 510(k) NO: K160425(Traditional) ATTN: ARMIN ZEHTABCHI PHONE NO : 949 2251234 2212 Dupont Drive, Suite P SE DECISION MADE: 15-JUL-16 Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ActiveCare Home MEDICAL COMPRESSION SYSTEMS (DBN) 510(k) NO: K160431(Traditional) ATTN: YAKI BARAK PHONE NO : 972 4 6266630 12 HA'ILAN STREET, PO BOX 75 SE DECISION MADE: 13-JUL-16 OR AKIVA IL 30600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V-PRO® 1 Plus and V-PRO® maX Low Temperature STERIS CORPORATION 510(k) NO: K160433(Traditional) ATTN: BILL BRODBECK PHONE NO : 440 3927690 5960 HEISLEY ROAD SE DECISION MADE: 06-JUL-16 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SunTech CT40 Spot-check Vital Signs Device SUNTECH MEDICAL 510(k) NO: K160439(Abbreviated) ATTN: CHUCK SETZER PHONE NO : 919 6542334 507 AIRPORT BLVD SUITE 117 SE DECISION MADE: 06-JUL-16 MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTLINE HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K160448(Traditional) ATTN: JOEL FAULKNER PHONE NO : 801 7737798 5675 WEST 300 SOUTH SE DECISION MADE: 12-JUL-16 SALT LAKE CITY UT 84101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Spinal Elements' Spinous Process Plate System Spinal Elements Inc. 510(k) NO: K160465(Traditional) ATTN: Julie Lamothe PHONE NO : 760 6071816 3115 Melrose Dr., Suite 200 SE DECISION MADE: 28-JUL-16 Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SculpSure CYNOSURE, INC. 510(k) NO: K160470(Traditional) ATTN: Aastha Kohli PHONE NO : 781 9932394 5 CARLISLE ROAD SE DECISION MADE: 21-JUL-16 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: The Luco Hybrid OSA Appliance LUCO HYBRID OSA APPLIANCE INC. 510(k) NO: K160477(Traditional) ATTN: Ken Luco PHONE NO : 1 613 5446019 1419 BUTTERNUT CREEK ROAD SE DECISION MADE: 29-JUL-16 KINGSTON CA K7L 4V3 510(k) STATEMENT DEVICE: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater Tandem Diabetes Care, Inc. 510(k) NO: K160482(Traditional) ATTN: Michael Sarrasin PHONE NO : 858 3666900 11045 Roselle Street SE DECISION MADE: 13-JUL-16 San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RI Witness Embryology Heated Plate RESEARCH INSTRUMENTS LIMITED 510(k) NO: K160504(Traditional) ATTN: Wendy Hassan PHONE NO : 44 1326 372753 BICKLAND INDUSTRIAL PARK SE DECISION MADE: 18-JUL-16 FALMOUTH GB TR11 4TA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEONI ORION System LEONI CIA CABLE SYSTEM 510(k) NO: K160518(Traditional) ATTN: AURELIE GENHO PHONE NO : 33 0237 912182 5 AVE VICTOR HUGO SE DECISION MADE: 14-JUL-16 CHARTRES FR 28000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALO Grand ULTRADENT PRODUCTS, INC. 510(k) NO: K160551(Special) ATTN: Marie Hess PHONE NO : 801 5534610 505 WEST 10200 SOUTH SE DECISION MADE: 13-JUL-16 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO.,LTD. 510(k) NO: K160557(Traditional) ATTN: SARAH SU PHONE NO : 886 2 82271300 1201 9F, NO.186, JIAN YI RD SE DECISION MADE: 06-JUL-16 ZHONGHE DISTRICT, NEW TAIPEI CITY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NeuGuide POP Medical Solutions 510(k) NO: K160569(Traditional) ATTN: Guy Ohad PHONE NO : 972 3 7684948 27 Habarzel ST. SE DECISION MADE: 06-JUL-16 Tel Aviv IL 6971039 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PacEndo Chlorhexidine PAC-DENT INTERNATIONAL, INC. 510(k) NO: K160577(Traditional) ATTN: Wenying Zhu PHONE NO : 909 8390888 670 ENDEAVOR CIRCLE SE DECISION MADE: 25-JUL-16 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEAUTIFIL II LS SHOFU DENTAL CORPORATION 510(k) NO: K160596(Traditional) ATTN: Mauro Malzyner PHONE NO : 760 7363277 1225 STONE DRIVE SE DECISION MADE: 27-JUL-16 SAN MARCOS CA 92078 510(k) STATEMENT DEVICE: Cure™ Anterior Cervical Plate (ACP) System MEDITECH SPINE, LLC 510(k) NO: K160604(Traditional) ATTN: BRUCE DUNAWAY PHONE NO : 678 9745287 1447 PEACHTREE ST NE SUITE 440 SE DECISION MADE: 01-JUL-16 ATLANTA GA 30309 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MectaLIF Anterior Stand-Alone MEDACTA INTERNATIONAL 510(k) NO: K160605(Traditional) ATTN: MICHAEL G. LOITERMAN PHONE NO : 41 91 6966060 STRADA REGINA SE DECISION MADE: 21-JUL-16 CASTEL SAN PIETRO CH CH 6874 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PicoWay Laser System SYNERON CANDELA CORPORATION 510(k) NO: K160607(Traditional) ATTN: Ruthie Amir PHONE NO : 508 3587400 330 530 BOSTON POST ROAD SE DECISION MADE: 05-JUL-16 Wayland MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Soberlink Cellular Device and Sober Sky Web Portal SOBERLINK HEALTHCARE LLC 510(k) NO: K160613(Traditional) ATTN: JENNA COSTA PHONE NO : 714 9757200 16787 BEACH BLVD #211 SE DECISION MADE: 14-JUL-16 HUNTINGTON BEACH CA 92647 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: InPen COMPANION MEDICAL, INC. 510(k) NO: K160629(Traditional) ATTN: JASPER BENKE PHONE NO : 858 5220252 16486 BERNARDO CENTER, DRIVE SUITESE DECISION MADE: 26-JUL-16 SAN DIEGO CA 92128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Keos Lumbar IBFD KEOS 510(k) NO: K160631(Traditional) ATTN: MARK F. SCHENK PHONE NO : 610 5078255 1824 COLONIAL VILLAGE LANE SE DECISION MADE: 15-JUL-16 LANCASTER PA 17601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Atteris No-Sting Skin Protectant ROCHAL INDUSTRIES LLC 510(k) NO: K160684(Traditional) ATTN: WILLIAM J. COULSTON PHONE NO : 210 8706534 12719 CRANES MILL SE DECISION MADE: 26-JUL-16 SAN ANTONIO TX 78230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: myPatch-s DMS-SERVICE LLC 510(k) NO: K160704(Traditional) ATTN: LYNDA COLE PHONE NO : 855 4072824 11845 W. OLYMPIC BLVD STE 880W SE DECISION MADE: 15-JUL-16 LOS ANGELES CA 90064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AccuLIF TL and PL Cage STRYKER CORPORATION 510(k) NO: K160715(Traditional) ATTN: AAKASH JAIN PHONE NO : 201 7498074 2 PEARL COURT SE DECISION MADE: 08-JUL-16 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CorticaLINK Spinal Fusion Platform FACETLINK DBA LINKSPINE 510(k) NO: K160722(Traditional) ATTN: MASSIMO CALAFIORE PHONE NO : 973 6274171 101 ROUNDHILL DRIVE SE DECISION MADE: 07-JUL-16 ROCKAWAY NJ 07866 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOOK PTFE Suture Surgical Specialties Corporation 510(k) NO: K160744(Traditional) ATTN: Karen Sanchez PHONE NO : 484 5574996 Corredor Tijuana-Rosarito 2000, #2SE DECISION MADE: 13-JUL-16 Tijuana MX 22235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Angel Catheter BIO2 MEDICAL, INC. 510(k) NO: K160747(Traditional) ATTN: CHRISTOPHER E. BANAS PHONE NO : 720 8335660 4670 TABLE MOUNTAIN DRIVE SE DECISION MADE: 28-JUL-16 GOLDEN CO 80403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap AHLSTROM NONWOVENS LLC 510(k) NO: K160755(Traditional) ATTN: GARY JACKSON PHONE NO : 860 6548556 2 ELM STREET SE DECISION MADE: 27-JUL-16 WINDSOR LOCKS CT 06096 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) AXIS-SHIELD DIAGNOSTICS LIMITED 510(k) NO: K160757(Traditional) ATTN: CLAIRE I. DORA PHONE NO : 44 013 82422000 232 THE TECHNOLOGY PARK LUNA PLACE SE DECISION MADE: 26-JUL-16 DUNDEE GB DD2 1XA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PeriCoach OTC ANALYTICA LTD. 510(k) NO: K160758(Traditional) ATTN: GEOFF DALY PHONE NO : 61 7 32781950 320 ADELAIDE STREET SE DECISION MADE: 11-JUL-16 BRISBANE AU 4000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens CooperVision, Inc. 510(k) NO: K160803(Traditional) ATTN: Roya Borazjani PHONE NO : 925 6213723 6150 Stoneridge Mall Rd., Suite 37SE DECISION MADE: 13-JUL-16 Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAFIX(TM) Advance Tibial Fastener System MEDOS INTERNATIONAL SARL 510(k) NO: K160804(Traditional) ATTN: KRISTINE CHRISTO PHONE NO : 508 8283359 CHEMIN-BLANC 38, CASE POSTALE SE DECISION MADE: 19-JUL-16 LE LOCLE CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EasyStep STRYKER GMBH 510(k) NO: K160813(Traditional) ATTN: Garry T. Hayeck PHONE NO : 201 8316802 325 CORPORATE DRIVE SE DECISION MADE: 26-JUL-16 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Integra External Fixation System Ascension Orthopedics 510(k) NO: K160830(Special) ATTN: Jayana Kenana PHONE NO : 609 9362657 8700 Cameron Road, Suite 100 SE DECISION MADE: 06-JUL-16 Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AmplifEYE MEDIVATORS, INC. 510(k) NO: K160846(Traditional) ATTN: Jeff Kasoff PHONE NO : 936 5214213 3150 POLLOK DR. SE DECISION MADE: 14-JUL-16 CONROE TX 77303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Wingman 18 Crossing Catheter ReFlow Medical, Inc. 510(k) NO: K160848(Traditional) ATTN: Rebecca K Pine PHONE NO : 760 8095178 1003 Calle Sombra SE DECISION MADE: 14-JUL-16 San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) CONTAMAC LTD. 510(k) NO: K160859(Traditional) ATTN: ROB MCGREGOR PHONE NO : 44 179 9542000 CARLTON HOUSE SHIRE HILL SE DECISION MADE: 13-JUL-16 SAFFRON WALDEN GB cb11 3au 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PBS(-), Phosphate Buffered Saline KITAZATO BIOPHARMA CO., LTD. 510(k) NO: K160863(Traditional) ATTN: FUTOSHI INOUE PHONE NO : 81 545 662202 81 NAKIJIMA SE DECISION MADE: 28-JUL-16 FUJI JP 416-0907 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating CARDINAL HEALTH, INC. 510(k) NO: K160875(Traditional) ATTN: Megan Middaugh PHONE NO : 847 8876812 1500 WAUKEGAN RD SE DECISION MADE: 11-JUL-16 WAUKEGAN IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cook Intraosseous Infusion Needles COOK INCORPORATED 510(k) NO: K160887(Special) ATTN: JULIA FERGUSON PHONE NO : 812 3353575 104554 750 DANIELS WAY SE DECISION MADE: 26-JUL-16 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANAROCare ReJu M.I.TECH CO.,LTD 510(k) NO: K160893(Traditional) ATTN: HWANG MI-SUNG PHONE NO : 82 31 6625645 174, HABUK 2-GIL, JINWI-MYEON SE DECISION MADE: 27-JUL-16 Pyeongtaek-si KR 17706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASHAPE POWER SYSTEM SYNERON MEDICAL LTD 510(k) NO: K160896(Traditional) ATTN: Ruthie Amir PHONE NO : 972 73 2442200 TAVOR BUILDING, INDUSTRIAL ZONE, PSE DECISION MADE: 08-JUL-16 Yokneam Illit IL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Expedium Spine System, VIPER and VIPER 2 Systems MEDOS INTERNATIONAL SARL 510(k) NO: K160904(Traditional) ATTN: Karen Sylvia PHONE NO : 508 9773804 CHEMIN-BLANC 38 SE DECISION MADE: 01-JUL-16 LE LOCLE CH 2400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device SPINEOLOGY INC. 510(k) NO: K160906(Traditional) ATTN: JACQUELINE A HAUGE PHONE NO : 651 2568500 7800 3RD STREET, SUITE 600 SE DECISION MADE: 14-JUL-16 ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DePuy Actis DuoFix Hip Prosthesis DEPUY (IRELAND) 510(k) NO: K160907(Traditional) ATTN: Jaime Weeks PHONE NO : 574 3727591 LOUGHBEG RINGASKIDDY SE DECISION MADE: 19-JUL-16 Co. Cork IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS CORPORATION 510(k) NO: K160908(Traditional) ATTN: ANTHONY PIOTRKOWSKI PHONE NO : 440 3927437 5960 HEISLEY RD SE DECISION MADE: 22-JUL-16 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elecsys Syphilis ROCHE DIAGNOSTICS 510(k) NO: K160910(Traditional) ATTN: ANGELO PEREIRA PHONE NO : 317 5213544 9115 HAGUE RD SE DECISION MADE: 28-JUL-16 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8ch Foot Ankle Coil Shenzhen RF Tech Co., Ltd. 510(k) NO: K160935(Traditional) ATTN: Ke Xi PHONE NO : 086 755 26641989 2-F, Bld4, Juhui Industrial Park, SE DECISION MADE: 28-JUL-16 Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System USA LASER BIOTECH INC. 510(k) NO: K160947(Traditional) ATTN: NELSON MARQUINA PHONE NO : 804 3772234 9210 FOREST HILL AVENUE SUITE B-3 SE DECISION MADE: 05-JUL-16 RICHMOND VA 23235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tritanium® PL Cage STRYKER 510(k) NO: K160955(Traditional) ATTN: Deirdre Jayko PHONE NO : 201 7488339 2 Pearl Court SE DECISION MADE: 21-JUL-16 Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LD-Oxi system LD TECHNOLOGY LLC 510(k) NO: K160956(Special) ATTN: Albert MAAREK PHONE NO : 305 3799900 100N. Biscayne Blvd, suite 500 SE DECISION MADE: 06-JUL-16 Miami FL 33132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mozec NC-Rx PTCA Baloon Dilatation Catheter MERIL LIFE SCIENCES PRIVATE LIMITE510(k) NO: K160961(Traditional) ATTN: Utpal Thakor PHONE NO : 91 960 1260306 Bilakhia House, Survey No. 135/139SE DECISION MADE: 30-JUL-16 Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PolyDev Soft Contact Lenses Polydev Ltd. 510(k) NO: K160977(Traditional) ATTN: John Mulvihill PHONE NO : 353 876 873128 Tinure Rd SE DECISION MADE: 13-JUL-16 Collon IE 510(k) STATEMENT DEVICE: LITe BIO Delivery System STRYKER CORPORATION 510(k) NO: K160978(Traditional) ATTN: Meriam Gabera PHONE NO : 201 7608043 2 PEARL COURT SE DECISION MADE: 08-JUL-16 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MultiScan G-Arm System BEIJING EAST WHALE IMAGING TECHNOL510(k) NO: K160984(Traditional) ATTN: SHARON FAN PHONE NO : 86 10 67892355 8866 B2-2 NEW CITY INDUSTRIAL PARK, NO.SE DECISION MADE: 20-JUL-16 BEIJING CN 100023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ReWalk(TM) REWALK ROBOTICS INC. 510(k) NO: K160987(Special) ATTN: JOHN HAMILTON PHONE NO : 508 2511154 33 LOCKE DRIVE SE DECISION MADE: 22-JUL-16 MARLBOROUGH MA 01752 510(k) STATEMENT DEVICE: Biopor, AOC Porous Polyethylene, Cerepor CEREMED, INC. 510(k) NO: K160988(Traditional) ATTN: CHELSEA MITCHELL PHONE NO : 310 8152125 3643 LENAWEE AVE. SE DECISION MADE: 14-JUL-16 LOS ANGELES CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm Dunamis LLC 510(k) NO: K160996(Traditional) ATTN: Prithvi Raj Chavan PHONE NO : 731 2172533 693 Sherling Lake Rd Apt 122 SE DECISION MADE: 06-JUL-16 Greenville AL 36037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GC85A SAMSUNG ELECTRONICS CO., LTD. 510(k) NO: K160997(Traditional) ATTN: CHULSIN KIM PHONE NO : 82 312 007661 129, SAMSUNG-RO YEONGTONG-GU SE DECISION MADE: 06-JUL-16 SUWON-SI, KR 443-742 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE HARTALEGA SDN. BHD. 510(k) NO: K161008(Traditional) ATTN: KUAN KAM HON PHONE NO : 603 62801733 DATARAN SD PJU 9 SE DECISION MADE: 28-JUL-16 BANDAR SRI DAMANSARA MY 52200 510(k) STATEMENT DEVICE: Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K161009(Traditional) ATTN: PAUL BIGGINS PHONE NO : 714 6697808 1385 SHIMOISHIGAMI SE DECISION MADE: 22-JUL-16 OTAWARA-SHI JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Easy-Load Lens Delivery System Bausch and Lomb, Inc. 510(k) NO: K161012(Special) ATTN: Joyce Zhong PHONE NO : 949 3985764 50 Technology Drive SE DECISION MADE: 06-JUL-16 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XSTAT-12, 3-Pack, XSTAT-12, 1-Pack REVMEDX, INC. 510(k) NO: K161020(Traditional) ATTN: AMY K. POINTER PHONE NO : 503 2182172 25999 SW CANYON CREEK ROAD SUITE CSE DECISION MADE: 28-JUL-16 WILSONVILLE OR 97070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K2M Growing Spine System K2M, Inc. 510(k) NO: K161028(Traditional) ATTN: Nancy Giezen PHONE NO : 571 9192000 751 Miller Drive SE SE DECISION MADE: 22-JUL-16 Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) ASSURE TECH (HANGZHOU) CO., LTD. 510(k) NO: K161044(Traditional) ATTN: SHISHENG LING PHONE NO : 86 571 88868960 NO. 10, XIYUANSAN RD., WESTLAKE ECSE DECISION MADE: 06-JUL-16 HANGZHOU CN 310030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Conventus Orthopaedics Ulna Fixation System CONVENTUS ORTHOPAEDICS, INC. 510(k) NO: K161048(Traditional) ATTN: KENT LIND PHONE NO : 763 5155003 10200 73RD AVENUE NORTH, SUITE 122SE DECISION MADE: 26-JUL-16 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OsteoFab Patient Specific Facial Device OXFORD PERFORMANCE MATERIALS, INC.510(k) NO: K161052(Special) ATTN: Leigh Ayres PHONE NO : 860 6989300 30 S Satellite Road SE DECISION MADE: 20-JUL-16 South Windsor CT 06074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 Fuji Dynamics Ltd 510(k) NO: K161055(Traditional) ATTN: Kam Tim Ng PHONE NO : 852 27864218 1-3, 23/F., Laws Commercial Plaza,SE DECISION MADE: 12-JUL-16 Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cannulated Screw MIAMI DEVICE SOLUTIONS, LLC 510(k) NO: K161058(Traditional) ATTN: MARKKU BIEDERMANN PHONE NO : 786 4221400 7620 NW 25TH STREET UNIT 3 SE DECISION MADE: 29-JUL-16 MIAMI FL 33122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder Free Grey Vinyl Examination Gloves ZIBO FLOURISH TRADING CO., LTD. 510(k) NO: K161072(Traditional) ATTN: KOU LINGLING PHONE NO : 86 0533 3819144 NAQI ROAD, ZHANGDIAN DISTRICT SE DECISION MADE: 14-JUL-16 ZIBO CN 255000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: sensiLight Mini EL GLOBAL TRADE LTD 510(k) NO: K161089(Traditional) ATTN: YAEL LIEBES-PEER PHONE NO : 972 978 89067 8 TZORAN ST, P.O. BOX 8242 SE DECISION MADE: 08-JUL-16 NETANYA IL 4250604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLANT Online Case Review and SIMPLANT Editor DENTSPLY SIRONA 510(k) NO: K161118(Traditional) ATTN: HELEN LEWIS PHONE NO : 717 4871332 221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 28-JUL-16 York PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload CARDICA, INC. 510(k) NO: K161137(Traditional) ATTN: Greg Watson PHONE NO : 949 4129808 900 Saginaw Dr SE DECISION MADE: 20-JUL-16 Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: St. Louis Band ORTHOMERICA PRODUCTS, INC. 510(k) NO: K161138(Traditional) ATTN: DAVID C. KERR PHONE NO : 407 2906592 6333 NORTH ORANGE BLOSSOM TRAIL SE DECISION MADE: 20-JUL-16 ORLANDO FL 32810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set DIASORIN, INC. 510(k) NO: K161139(Traditional) ATTN: JOHN WALTER PHONE NO : 651 4399710 1951 NORTHWESTERN AVE. SE DECISION MADE: 22-JUL-16 STILLWATER MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS OCT Spinal System MEDICREA INTERNATIONAL S.A 510(k) NO: K161149(Traditional) ATTN: David Ryan PHONE NO : 33 472 018787 14 PORTE DU GRAND LYON SE DECISION MADE: 11-JUL-16 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs SPR THERAPEUTICS, LLC 510(k) NO: K161154(Traditional) ATTN: Kathryn Stager PHONE NO : 216 3789108 22901 MILLCREEK BLVD., SUITE 110 SE DECISION MADE: 23-JUL-16 CLEVELAND OH 44122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Origin Coxa Vara Hip Stem SIGNATURE ORTHOPAEDICS PTY LTD. 510(k) NO: K161155(Traditional) ATTN: Declan Brazil PHONE NO : 61 294 285181 7 SIRIUS ROAD SE DECISION MADE: 19-JUL-16 LANE COVE AU 2066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory HITACHI, LTD. 510(k) NO: K161163(Traditional) ATTN: Naoya Nishimura PHONE NO : 81 362 843741 2-16-1 HIGACHI-UENO TAITO-KU SE DECISION MADE: 13-JUL-16 Tokyo JP 10-0015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL LIOFILCHEM S.R.L. 510(k) NO: K161175(Traditional) ATTN: FABIO BRACCO PHONE NO : 39 085 8930745 64026 ROSETO DEGHLI SE DECISION MADE: 12-JUL-16 ABRUZZI IT 510(k) STATEMENT DEVICE: Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System ZIMMER GMBH 510(k) NO: K161192(Special) ATTN: ROBERTO TOMMASINI PHONE NO : 41 58 8548264 SULZERALLEE 8 SE DECISION MADE: 08-JUL-16 WINTERTHUR CH 8404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 USA LASER BIOTECH INC. 510(k) NO: K161198(Traditional) ATTN: NELSON MARQUINA PHONE NO : 804 3772234 9210 FOREST HILL AVENUE SUITE B-3 SE DECISION MADE: 26-JUL-16 RICHMOND VA 23235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Gianturco-Roehm Bird’s Nest Vena Cava Filter COOK INCORPORATED 510(k) NO: K161218(Traditional) ATTN: Jessica Swafford PHONE NO : 812 3353575 104260 750 DANIELS WAY SE DECISION MADE: 22-JUL-16 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TransContinental® M Spacers and InterContinental® Plate-Spacers GLOBUS MEDICAL INC. 510(k) NO: K161223(Traditional) ATTN: KELLY J. BAKER PHONE NO : 610 9301800 1670 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 15-JUL-16 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) BIOMERIEUX, INC 510(k) NO: K161227(Traditional) ATTN: CHERECE L. JONES PHONE NO : 314 7318684 595 ANGLUM RD. SE DECISION MADE: 20-JUL-16 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-scan Esaote S.p.A. 510(k) NO: K161238(Special) ATTN: Donatella Ragghianti PHONE NO : 011 39 0106547259 Via Siffredi 58 SE DECISION MADE: 08-JUL-16 Genovo IT 16153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TheraCem BISCO, INC. 510(k) NO: K161256(Traditional) ATTN: Ryan Hobson PHONE NO : 847 5346143 1100 WEST IRVING PARK ROAD SE DECISION MADE: 29-JUL-16 SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive® VersaTie System NUVASIVE, INCORPORATED 510(k) NO: K161265(Traditional) ATTN: CYNTHIA ADAMS PHONE NO : 858 3204549 7475 LUSK BLVD. SE DECISION MADE: 15-JUL-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: da Vinci Xi Surgical System Intuitive Surgical, Inc. 510(k) NO: K161271(Special) ATTN: Brandon Hansen PHONE NO : 408 5237485 1266 Kifer Road SE DECISION MADE: 11-JUL-16 Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cool Renewal COOL RENEWAL, LLC 510(k) NO: K161296(Traditional) ATTN: ASHLEY RAINS PHONE NO : 615 8440132 2515 EUGENIA AVENUE, SUITE 103 SE DECISION MADE: 06-JUL-16 NASHVILLE TN 37211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PC ECG EDAN INSTRUMENTS, INC. 510(k) NO: K161302(Traditional) ATTN: ERICO LI PHONE NO : 86 7552 6858736 3/F - B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 01-JUL-16 SHENZHEN CN 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Habib EUS RFA EMCISION LTD. 510(k) NO: K161305(Traditional) ATTN: FRANCOIS POULIN PHONE NO : 1 514 9949649 DU CANE ROAD SE DECISION MADE: 07-JUL-16 LONDON GB W12 0HS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE FLEXICARE MEDICAL LIMITED 510(k) NO: K161314(Third Party - Traditional) ATTN: JOEL BIDDLE PHONE NO : 44 144 3474560 CYNON VALLEY BUSINESS PARK SE DECISION MADE: 06-JUL-16 MOUNTAIN ASH GB CF45 4ER 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TightRail Sub-C Rotating Dilator Sheath Spectranetics, Inc. 510(k) NO: K161333(Traditional) ATTN: Stephanie Byrum PHONE NO : 719 4472000 9965 Federal Drive SE DECISION MADE: 08-JUL-16 Colorado Springs CO 80921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CryoDose H or Similar NUANCE MEDICAL, LLC 510(k) NO: K161337(Traditional) ATTN: MARC LIEBERMAN PHONE NO : 760 5854849 5931 Sea Lion Place, Suite 113 SE DECISION MADE: 12-JUL-16 Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR SEDECAL SA 510(k) NO: K161345(Special) ATTN: Ma Luisa Gomez de Aguero PHONE NO : 34 91 6280544 PELAYA, 9 POL.; POL. IND. "RIO DE SE DECISION MADE: 06-JUL-16 ALGETE ES 28110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System Esaote S.p.A 510(k) NO: K161359(Traditional) ATTN: Massimo Polignano PHONE NO : 39 010 65471 Via A. Siffredi 58 SE DECISION MADE: 19-JUL-16 Genova IT 16153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVEREST Spinal System K2M, Incorporated 510(k) NO: K161369(Special) ATTN: NANCY GIEZEN PHONE NO : 571 9192000 600 HOPE PARKWAY SE SE DECISION MADE: 21-JUL-16 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LVivo Software Application DIACARDIO, LTD. 510(k) NO: K161382(Traditional) ATTN: Michal Yaacobi PHONE NO : 972 777 648318 HAENERGIA STREET 77 SE DECISION MADE: 28-JUL-16 Be’er Sheva IL 8496500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEC Model M13 Source Production and Equipment Co510(k) NO: K161395(Traditional) ATTN: Kelley Richardt PHONE NO : 504 4649471 113 Teal Street SE DECISION MADE: 06-JUL-16 Saint Rose LA 70087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Genesys Spine Apache® Lateral Lumbar Interbody Fusion System Genesys Spine 510(k) NO: K161404(Special) ATTN: Dave Lamb PHONE NO : 512 3817904 1250 Capital of Texas of Highway SSE DECISION MADE: 21-JUL-16 Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ascential IBD PEEKc Spacer Stryker Spine 510(k) NO: K161407(Special) ATTN: Tina Mornak PHONE NO : 201 7608193 2 Pearl Court SE DECISION MADE: 15-JUL-16 Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Multi Modality Viewer VITAL IMAGES, INC. 510(k) NO: K161419(Traditional) ATTN: KATIE RYAN PHONE NO : 952 4879793 5850 OPUS PARKWAY, SUITE 300 SE DECISION MADE: 13-JUL-16 MINNETONKA MN 55343-4414 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pirouette 035 ArraVasc Limited 510(k) NO: K161427(Special) ATTN: Aoife Donoghue PHONE NO : 353 91 758939 2 Ballybrit Business Park SE DECISION MADE: 30-JUL-16 Galway IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ekso™ (version 1.1) and Ekso GT™ (version 1.2) EKSO BIONICS, INC. 510(k) NO: K161443(Traditional) ATTN: Thomas Looby PHONE NO : 510 9841761 1414 HARBOUR WAY SOUTH, SUITE 1201SE DECISION MADE: 19-JUL-16 RICHMOND VA 94804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BostonSight PD Prosthetic Device BostonSight 510(k) NO: K161461(Traditional) ATTN: Gene Guselli PHONE NO : 781 7267503 464 Hillside Avenue, Suite 205 SE DECISION MADE: 25-JUL-16 Needham MA 02494 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VertiForm Posterior Fixation System NEXT ORTHOSURGICAL 510(k) NO: K161499(Special) ATTN: ELLEN YARNALL PHONE NO : 760 2953600 3270 CORPORATE VIEW, SUITE A SE DECISION MADE: 29-JUL-16 VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cianna Medical SAVI Scout Reflector and SAVI Scout System CIANNA MEDICAL, INC. 510(k) NO: K161507(Traditional) ATTN: GARY MOCNIK PHONE NO : 949 3600059 134 6 JOURNEY SUITE 125 SE DECISION MADE: 29-JUL-16 ALISO VIEJO CA 92656 510(k) STATEMENT DEVICE: 3D OCT-1 Maestro Topcon Corporation 510(k) NO: K161509(Traditional) ATTN: Charles Reisman PHONE NO : 201 5995283 75-1 Hasunuma-cho, Itabashi-ku SE DECISION MADE: 28-JUL-16 Tokyo JP 174-8580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDIGO Aspiration System Penumbra, Inc. 510(k) NO: K161523(Special) ATTN: Aditi Kolla PHONE NO : 510 9952010 One Penumbra Place SE DECISION MADE: 01-JUL-16 Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Elect510(k) NO: K161525(Traditional) ATTN: Wu Zicui PHONE NO : 86 755 81885658 Mindray Building, Keji 12th Road SSE DECISION MADE: 13-JUL-16 Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 Philips Medizin Systeme Boeblingen510(k) NO: K161531(Special) ATTN: Markus Stacha PHONE NO : 49 7031 4632840 Hewlett-Packard-Str.-2 SE DECISION MADE: 01-JUL-16 Boeblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD SafeAssist BECTON, DICKINSON AND COMPANY 510(k) NO: K161553(Special) ATTN: Meriam Youssef PHONE NO : 201 8476557 1 BECTON DR SE DECISION MADE: 06-JUL-16 Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: truFreeze System CSA MEDICAL, INC. 510(k) NO: K161557(Traditional) ATTN: SHERRIE COVAL-GOLDSMITH PHONE NO : 781 5384720 91 HARTWELL AVENUE SE DECISION MADE: 26-JUL-16 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating BOVIE MEDICAL CORPORATION 510(k) NO: K161558(Traditional) ATTN: Rubiela Maldonado PHONE NO : 727 8038508 5115 ULMERTON ROAD SE DECISION MADE: 29-JUL-16 CLEARWATER FL 33760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland 510(k) NO: K161563(Traditional) ATTN: Jeanette Becker PHONE NO : 31 6 11386380 VEENPLUIS 4-6 SE DECISION MADE: 29-JUL-16 BEST NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS LP Spinal System MEDICREA INTERNATIONAL S.A. 510(k) NO: K161627(Traditional) ATTN: DAVID RYAN PHONE NO : 33 472 018787 14 PORTE DU GRAND LYON SE DECISION MADE: 29-JUL-16 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMMI GENERAL EQUIPMENT FOR MEDICAL IMAG510(k) NO: K161631(Special) ATTN: JOSE MONTES PHONE NO : 34 96 3722472 EDUARDO PRIMO YUFERA, N 3 SE DECISION MADE: 28-JUL-16 VALENCIA ES 46012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Penumbra System ACE 68 Reperfusion Catheter Penumbra, Inc. 510(k) NO: K161640(Special) ATTN: Charles DeNault PHONE NO : 510 7483302 One Penumbra Place SE DECISION MADE: 12-JUL-16 Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FlexSeal Introducer Sheath with Hydrophilic Coating LIBRA MEDICAL INC. 510(k) NO: K161659(Third Party - Traditional) ATTN: SEW-WAH TAY PHONE NO : 612 8016782 8401 73RD AVE NORTH SUITE 63 SE DECISION MADE: 15-JUL-16 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) CONFORMIS, INC. 510(k) NO: K161668(Special) ATTN: AMITA SHAH PHONE NO : 781 3459164 28 CROSBY DR. SE DECISION MADE: 15-JUL-16 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Waterlase Express Biolase, Inc. 510(k) NO: K161669(Traditional) ATTN: Alicia Mszyca PHONE NO : 949 2268471 4 Cromwell SE DECISION MADE: 28-JUL-16 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: syngo®.via protoNeo (Version VA10A) SIEMENS HEALTHCARE GMBH 510(k) NO: K161685(Third Party - Traditional) ATTN: LAUREN BENTLEY PHONE NO : 610 4486104 HENKESTRASSE 127 SE DECISION MADE: 11-JUL-16 ERLANGEN DE 91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Threshold™ Pedicular Fixation System Spineology Inc. 510(k) NO: K161694(Special) ATTN: JACQUELINE A. HAUGE PHONE NO : 651 2568500 7800 3rd Street N, Suite 600 SE DECISION MADE: 15-JUL-16 St. Paul MN 55128-5455 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITRUVIAN ULTIMATE ASPIRATOR BLACK & BLACK SURGICAL, INC. 510(k) NO: K161722(Third Party - Traditional) ATTN: CYNTHIA REES PHONE NO : 770 4144880 5238 ROYAL WOODS PKWY, SUITE 170 SE DECISION MADE: 26-JUL-16 TUCKER GA 30084 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: E-Pack Procedure Kit ETHICON, INC. 510(k) NO: K161726(Special) ATTN: ENZA DESERIO PHONE NO : 908 2182662 ROUTE 22 WM P.O. BOX 151 SE DECISION MADE: 12-JUL-16 SOMERVILLE NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medilas H Laser Fibers DORNIER MEDTECH AMERICA, INC. 510(k) NO: K161771(Special) ATTN: JOHN HOFFER PHONE NO : 770 5146163 1155 ROBERTS BLVD, SUITE 100 SE DECISION MADE: 28-JUL-16 KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON NX2 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc510(k) NO: K161787(Third Party - Traditional) ATTN: Shelly Pearce PHONE NO : 650 2790134 685 E MIDDLEFIELD RD SE DECISION MADE: 28-JUL-16 Mountain view CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CrossCath Support Catheter Cook Incorporated 510(k) NO: K161801(Special) ATTN: Jessica Swafford PHONE NO : 812 3353575 104260 750 Daniels Way SE DECISION MADE: 29-JUL-16 Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EnCor MRI Introducer Set, EnCor Probe Introducer SENORX, INC. 510(k) NO: K161805(Special) ATTN: SARAH MCCARTNEY PHONE NO : 480 6382954 1625 WEST 3RD STREET SE DECISION MADE: 19-JUL-16 TEMPE AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tina-quant Cystatin C Gen.2 Roche Diagnostics Operations (RDO)510(k) NO: K161817(Special) ATTN: Patrick Stimart PHONE NO : 317 5213954 9115 Hague Road SE DECISION MADE: 27-JUL-16 Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2D Quantitative Analysis PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K161839(Abbreviated) ATTN: JEANETTE BECKER PHONE NO : 31 611 621238 VEENPLUIS 4-6 SE DECISION MADE: 29-JUL-16 BEST NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bright Tanda Beauty Canada Inc. 510(k) NO: K161849(Special) ATTN: Bobae Kim PHONE NO : 212 2452999 202 11-380 Jamieson Parkway SE DECISION MADE: 29-JUL-16 Cambridge CA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls PHADIA AB 510(k) NO: K161899(Special) ATTN: Ulf Karlberg PHONE NO : 46 18 165000 RAPSGATAN 7P SE DECISION MADE: 28-JUL-16 UPPSALA SE 75137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Comfort Cover PRECISION DYNAMICS CORPORATION 510(k) NO: K161920(Third Party - Traditional) ATTN: SWARNA MUKUND PHONE NO : 661 2570233 27770 ENTERTAINMENT DRIVE, STE 200SE DECISION MADE: 15-JUL-16 VALENCIA CA 91355 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay KRONUS, INC. 510(k) NO: K161951(Special) ATTN: Brian Deis PHONE NO : 208 3774800 170 S. SENECA SPRINGS WAY, SUITE 1SE DECISION MADE: 22-JUL-16 STAR ID 83669 510(k) STATEMENT
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