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
The post FDA releases July 2016 510(k) clearances appeared first on MassDevice.
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(Reuters) – The reputation of the Karolinska Institute, one of Sweden’s top hospitals that awards the Nobel prize for medicine, has been badly damaged by allegations patients died as a result of a surgeon performing experimental operations without clearance, an official report said.
Private equity player Genstar Capital is reportedly shopping