510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2017
DEVICE: Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)
LI-TEK ELECTRONICS TECHNOLOGIES 510(k) NO: K161434(Traditional)
ATTN: BARRY YUAN PHONE NO : 0769 83117755
NO. 8-13, INDUSTRIAL PARK OF JINSHSE DECISION MADE: 28-SEP-17
DONGGUAN CITY CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
SHENZHEN HOMED MEDICAL DEVICE CO.,510(k) NO: K161586(Traditional)
ATTN: Shengming Shi PHONE NO : 86 755 29821675 8011
NO.2 BUILDING, LONGGU INDUSTRIAL ZSE DECISION MADE: 06-SEP-17
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Salter Labs Bubble Humidifier
SALTER LABS 510(k) NO: K161719(Traditional)
ATTN: MARA CALER PHONE NO : 760 7957094
2365 CAMINO VIDA ROBLE SE DECISION MADE: 21-SEP-17
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S4 Screw System™
SUBCHONDRAL SOLUTIONS 510(k) NO: K162171(Traditional)
ATTN: SHERYL MCCOY PHONE NO : 408 8919604
147 HILLBROOK DRIVE SE DECISION MADE: 07-SEP-17
LOS GATOS CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A.B. DENTAL DEVICES Dental Implants System
A. B. Dental Device Ltd. 510(k) NO: K162482(Traditional)
ATTN: Gabi Krauss PHONE NO : 972 8 8531388
19 Hayalomim St. SE DECISION MADE: 15-SEP-17
Ashdod IL 77101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Winback Back 3SE
WINBACK USA CORP 510(k) NO: K162828(Traditional)
ATTN: CHEICK KONGO PHONE NO :
302 HIGH PLAINS DR SE DECISION MADE: 18-SEP-17
DRIPPING SPRINGS TX 78620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann CARES Golden Ti/TiN Abutments
INSTITUT STRAUMANN AG 510(k) NO: K162848(Traditional)
ATTN: Christopher Klaczyk PHONE NO : 41 61 9651260
Peter Merian Weg 12 SE DECISION MADE: 22-SEP-17
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOWCARDIO SYSTEM
CONTEX INTERNATIONAL TECHNOLOGIES 510(k) NO: K162956(Abbreviated)
ATTN: RICARDO RODRIGUEZ PHONE NO : 905 6778324
2798 THAMESGATE DRIVE, UNITS 5&6 SE DECISION MADE: 22-SEP-17
MISSISSAUGA CA L4T 4E8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Finger Pulse Oximeter
SHENZHEN FITFAITH TECHNOLOGY CO.,L510(k) NO: K163135(Traditional)
ATTN: Yuan Junfeng PHONE NO : 86 0755 2954425380
AREA B, FLOOR 9, BUILDING D1, TANGSE DECISION MADE: 19-SEP-17
Guangming New District, Shenzhen 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BePOD® Foot Screws
Fournitures Hospitalieres Industri510(k) NO: K163148(Traditional)
ATTN: Patricia Donnard PHONE NO : 33 2 98556895
ZI de Kernevez - 6 rue Nobel SE DECISION MADE: 14-SEP-17
Quimper FR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fiagon Navigation System
FIAGON GMBH 510(k) NO: K163209(Traditional)
ATTN: Dirk Mucha PHONE NO : 49 3302 2012110
NEUENDORFSTRASSE 23B SE DECISION MADE: 14-SEP-17
HENNIGSDORF DE 16761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AnemoCheck
SANGUINA, LLC 510(k) NO: K163215(Traditional)
ATTN: ERIKA TYBURSKI PHONE NO : 305 3083267
575 14TH STREET SE DECISION MADE: 13-SEP-17
ATLANTA GA 30318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISEN-Goggles with Data Viewer
ISENT TECH & TRADING COMPANY,LTD. 510(k) NO: K163270(Traditional)
ATTN: MARTIN LIU PHONE NO : 86 10 51627072
RM509, BLDG A, CYBERTOWER, NO.2 ZHSE DECISION MADE: 25-SEP-17
BEIJING CN 100086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
HAMILTON MEDICAL AG 510(k) NO: K163283(Traditional)
ATTN: Steffen Boden PHONE NO : 41 58 6101842
VIA CRUSCH 8 SE DECISION MADE: 20-SEP-17
BONADUZ CH 7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
SPECTRA MEDICAL DEVICES 510(k) NO: K163292(Traditional)
ATTN: SCOTT HENDERSON PHONE NO : 978 6570889
260-H FORDHAM ROAD SE DECISION MADE: 08-SEP-17
WILMINGTON MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Senographe Pristina
GE Healthcare 510(k) NO: K163302(Traditional)
ATTN: Camille Vidal PHONE NO : 1 240 2805356
283 rue de la Miniere SE DECISION MADE: 01-SEP-17
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartEP
INTELLIGENT HEARING SYSTEMS 510(k) NO: K163326(Traditional)
ATTN: Edward Miskiel PHONE NO : 305 668 6102
6860 SW 81ST st Street SE DECISION MADE: 29-SEP-17
MIAMI FL 33143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIBotics Knee System
OMNllife Science Inc. 510(k) NO: K163338(Traditional)
ATTN: Daniel Decruppe PHONE NO : 800 448 6664
480 Paramount Drive SE DECISION MADE: 01-SEP-17
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Confirm Rx Insertable Cardiac Monitor (ICM) System
St. Jude Medical, Inc. 510(k) NO: K163407(Traditional)
ATTN: Jennifer Dunham PHONE NO : 818 3626822
15900 Valley View Ct. SE DECISION MADE: 29-SEP-17
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shanghai Sanyou PEEK Cage System
SHANGHAI SANYOU MEDICAL CO, LTD 510(k) NO: K163422(Traditional)
ATTN: David Fan PHONE NO : 86 21 58389980
1988 JIATANG ROAD SE DECISION MADE: 18-SEP-17
JIADIANG DISTRICT CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS Chemistry Products GLU Slides
Ortho Clinical Diagnostics 510(k) NO: K163433(Traditional)
ATTN: Darlene J. Phillips PHONE NO : 585 4534253
100 Indigo Creek Drive SE DECISION MADE: 18-SEP-17
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaviENT
ClaroNav Inc. 510(k) NO: K163439(Traditional)
ATTN: Ahmad Kolahi PHONE NO : 647 9511525
1140 Sheppard Avenue West - Unit 1SE DECISION MADE: 01-SEP-17
Toronto CA M3K 2A2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
Modern Medical Equipment Manufactu510(k) NO: K163442(Traditional)
ATTN: Thomas Tsz Fung Chan PHONE NO : 852 2420 9068
35-41 Tai Lin Pai Rd, Unit F 5th FSE DECISION MADE: 28-SEP-17
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GrindCare System
SUNSTAR SUISSE S.A. 510(k) NO: K163448(Traditional)
ATTN: Olivier Ducamp PHONE NO : 41 21 8210652
Route de Pallatex 11 SE DECISION MADE: 01-SEP-17
Etoy CH 1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurgiCube
SURGICUBE INTERNATIONAL B.V. 510(k) NO: K163455(Traditional)
ATTN: GER VIJFVINKEL PHONE NO : 31 018 1760660
SEGGELANT-NOORD 4 SE DECISION MADE: 28-SEP-17
VIERPOLDERS NL 3237 MG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
Radiometer Medical ApS 510(k) NO: K163462(Traditional)
ATTN: Per Pape Thomsen PHONE NO : 45 3827 3304
Aakandevej 21 SE DECISION MADE: 21-SEP-17
Broenshoej DK 2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
BMC MEDICAL.,LTD. 510(k) NO: K163464(Traditional)
ATTN: Jiang Huiqi PHONE NO : 86 10 51663880 705
ROOM 110 TOWER A FENGYU BUILDING, SE DECISION MADE: 05-SEP-17
Haidian CN 100036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: hemochroma PLUS System
IMMUNOSTICS, INC. 510(k) NO: K163465(Traditional)
ATTN: ANTOINETTE PRUSIK PHONE NO : 732 9180770
1750 BRIELLE AVE. A5 SE DECISION MADE: 08-SEP-17
OCEAN NJ 07712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Poseidon Ultrasound System
BUTTERFLY NETWORK, INC. 510(k) NO: K163510(Traditional)
ATTN: BRIAN SAWIN PHONE NO : 203 2046600
530 OLD WHITFIELD STREET SE DECISION MADE: 06-SEP-17
GUILFORD CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Thermometer
JOYTECH HEALTHCARE CO., LTD 510(k) NO: K163518(Traditional)
ATTN: Ren Yunhua PHONE NO : 86 571 81957767
No. 365, Wuzhou Road Yuhang EconomSE DECISION MADE: 19-SEP-17
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
Inova Diagnostics, Inc. 510(k) NO: K163525(Traditional)
ATTN: Peter Martis PHONE NO : 858 5869900 1399
9900 Old Grove Road SE DECISION MADE: 05-SEP-17
San Diego CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
INOVA DIAGNOSTICS, INC. 510(k) NO: K163538(Traditional)
ATTN: ROGER ALBESA PHONE NO : 858 5869900 1391
9900 OLD GROVE ROAD SE DECISION MADE: 06-SEP-17
SAN DIEGO CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MediClear PreOp
COVALON TECHNOLOGIES, INC. 510(k) NO: K163556(Traditional)
ATTN: KIM CROOKS PHONE NO : 905 5688400 265
1660 TECH AVENUE UNIT 5 SE DECISION MADE: 14-SEP-17
MISSISSSAUGA CA L4W 5S7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ecofit® Hip System
Implantcast GmbH 510(k) NO: K163577(Traditional)
ATTN: Juliane Hoeppner PHONE NO : 49 416 1744135
Lueneburger Schanze 26 SE DECISION MADE: 25-SEP-17
Buxtehude DE 21614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Psychemedics Microplate EIA for Benzodiazepines in Hair
Psychemedics Corporation 510(k) NO: K163590(Traditional)
ATTN: Virginia Hill PHONE NO : 310 2167776
5832 Uplander Way SE DECISION MADE: 15-SEP-17
Culver City CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pain Therapy Device
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K163611(Traditional)
ATTN: Sammy Li PHONE NO : 86 20 66393598
2nd Building, Juntuo Industry ParkSE DECISION MADE: 19-SEP-17
Guangzhou CN 511400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical ED34-i10T, Video Duodenoscope
PENTAX Medical 510(k) NO: K163614(Traditional)
ATTN: Kanchana Iyer PHONE NO : 800 4315880 5170
3 Paragon Drive SE DECISION MADE: 20-SEP-17
Montvale NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shotel Ankle Arthrodesis Nail System
BioPro, Inc. 510(k) NO: K163627(Traditional)
ATTN: Dave Mrak PHONE NO : 810 9827777 101
2929 Lapeer Road SE DECISION MADE: 14-SEP-17
Port Huron MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Health-e-Connect System with IDA
ALR TECHNOLOGIES 510(k) NO: K163664(Traditional)
ATTN: SIDNEY CHAN PHONE NO : 203 7621073
7400 BEAUFONT SPRINGS DRIVE, SUITESE DECISION MADE: 18-SEP-17
RICHMOND VA 23225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: neuro | inspire
Rensihaw plc 510(k) NO: K163666(Traditional)
ATTN: Roberto Liddi PHONE NO : 440 1453 524600
New Mills SE DECISION MADE: 15-SEP-17
Wotton-under-Edge GB GL12 8JR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
NEO COSMETIQUE 510(k) NO: K163674(Traditional)
ATTN: NATHALIE VERNIN PHONE NO : 331 49 465105
15 RUE MONTJOIE SE DECISION MADE: 22-SEP-17
SAINT DENIS FR 93212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook
ALN Implants Chirurgicaux 510(k) NO: K163699(Abbreviated)
ATTN: Alain Nigon PHONE NO : 33 494 010501
589 Chemin du Niel SE DECISION MADE: 08-SEP-17
Bormes les Mimosas FR 83230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BePOD® EZ Weil Screws
Fournitures Hospitalieres Industri510(k) NO: K163710(Traditional)
ATTN: Patricia Donnard PHONE NO : 33 2 98556898
Zi de Kernevez - 6 rue Nobel SE DECISION MADE: 08-SEP-17
Quimper FR 29000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Blood Collection Set
Medline Industries, Inc. 510(k) NO: K170002(Traditional)
ATTN: Matt Clausen PHONE NO : 847 6434785
One Medline Place SE DECISION MADE: 19-SEP-17
Mundelein IL 60060 510(k) STATEMENT
DEVICE: Eztetic BellaTek Encode Healing Abutments
BIOMET 3I 510(k) NO: K170013(Traditional)
ATTN: KRUPAL PATEL PHONE NO : 561 7766923
4555 RIVERSIDE DR SE DECISION MADE: 21-SEP-17
PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peel-Away Introducer Set
Cook Incorporated 510(k) NO: K170020(Traditional)
ATTN: Colin Jacob PHONE NO : 812 3353575 104965
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 28-SEP-17
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
Fysicon BV 510(k) NO: K170032(Traditional)
ATTN: C.W.A (Eric) Van Antwerpen PHONE NO : 31 412 653333
Hoogheuvelstraat 114 SE DECISION MADE: 08-SEP-17
Oss NL 5349 BA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XableCath Support Catheter
XABLECATH, INC. 510(k) NO: K170041(Traditional)
ATTN: RICK GAYKOWSKI PHONE NO : 617 4474000
417 S WAKARA WAY STE. 3510 SE DECISION MADE: 07-SEP-17
SALT LAKE CITY UT 84108-1457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: All-in-One Health Monitor, PC-303
Shenzhen Creative Industry Co., Lt510(k) NO: K170047(Traditional)
ATTN: Jia Wang PHONE NO : 86 755 26431671
2/F, Block 3, Nanyou Tian'an IndusSE DECISION MADE: 09-SEP-17
Shenzhen CN 518054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scanostics UTI Check Application Test System
Teco Diagnostics 510(k) NO: K170118(Traditional)
ATTN: Ling Koh PHONE NO : 714 4631111
1268 N Lakeview Ave SE DECISION MADE: 21-SEP-17
Anaheim CA 92807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Calix Lumbar Spinal Implant System
X-Spine Systems, Inc. 510(k) NO: K170119(Traditional)
ATTN: Charlene Brumbaugh PHONE NO : 937 8478400 2192
452 Alexandersville Rd. SE DECISION MADE: 29-SEP-17
Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDEPENDENCE® Spacers
Globus Medical Inc. 510(k) NO: K170157(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 25-SEP-17
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vesco Medical Nasoenteric Feeding Tubes
Vesco Medical, LLC 510(k) NO: K170162(Traditional)
ATTN: Chris O'Keefe PHONE NO : 614 9145991
692 N. High Street, Suite 205 SE DECISION MADE: 26-SEP-17
Columbus OH 43215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
CPT Sutures Co., Ltd. 510(k) NO: K170166(Traditional)
ATTN: Khoa Do PHONE NO : 84 8 38222228
8 Dao Tri Street SE DECISION MADE: 29-SEP-17
Phu Thuan Ward District 7 VN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Rad-97 and Accessories
MASIMO CORPORATION 510(k) NO: K170168(Traditional)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 2977592
52 DISCOVERY SE DECISION MADE: 14-SEP-17
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
Lumenis Ltd. 510(k) NO: K170179(Traditional)
ATTN: Amaya De Levie PHONE NO : 972 4 9599085
6 Hakidma Street PO Box 240 SE DECISION MADE: 18-SEP-17
Yokneam IL 2069204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prizma
G-Medical Innovations Ltd. 510(k) NO: K170181(Traditional)
ATTN: N. Epstein PHONE NO : 972 8 9584777
5 Openheimer St., Park Rabin SE DECISION MADE: 01-SEP-17
Rehovot IL 7670105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cetus system, Cetus probe
A.R.C. Laser GmbH 510(k) NO: K170183(Traditional)
ATTN: Angela Thyzel PHONE NO : 49 911 2177900
Bessemer St. 14 SE DECISION MADE: 27-SEP-17
Nurnberg DE 90411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: tremoFlo C-100 Airwave Oscillometry System
THORASYS Thoracic Medical Systems,510(k) NO: K170185(Traditional)
ATTN: Sebastien Jutras PHONE NO : 1 514 3848555 133
6560 Avenue de l'Esplanade Suite #SE DECISION MADE: 12-SEP-17
Montreal CA H2v 4l5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
Given Imaging Ltd. 510(k) NO: K170210(Traditional)
ATTN: Hilla Debby PHONE NO : 972 4 9097774
2 Hacarmet St New Industrial Park SE DECISION MADE: 01-SEP-17
Yoqneam IL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)
Andon health Co., Ltd 510(k) NO: K170231(Traditional)
ATTN: Yi Liu PHONE NO : 86 22 60526161
No.3 Jinping Street,Ya An Road, NaSE DECISION MADE: 15-SEP-17
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Thermometer
K-Jump Health Co., Ltd. 510(k) NO: K170262(Abbreviated)
ATTN: JM Lin PHONE NO : 886 2 22991378
No. 56, Wu Kung 5th Rd., New TaipeSE DECISION MADE: 28-SEP-17
New Taipei City TW 24890 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tri Auto ZX2
J. MORITA USA, INC. 510(k) NO: K170275(Traditional)
ATTN: KEISUKE MORI PHONE NO : 949 5819600
9 MASON SE DECISION MADE: 11-SEP-17
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA
Largan Medical Co. Ltd. 510(k) NO: K170286(Traditional)
ATTN: Amy Tien PHONE NO : 886 4 36000203
2F., No. 14, 23rd Rd., Taichung InSE DECISION MADE: 18-SEP-17
Taichung TW 40850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tri-Ex Extraction Balloon With Multiple Sizing
WILSON-COOK MEDICAL, INC 510(k) NO: K170292(Special)
ATTN: TIFFANNY A. THOMAS PHONE NO : 336 7440157 396680
4900 BETHANIA STATION ROAD SE DECISION MADE: 20-SEP-17
WINSTON-SALEM NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Entuit Start Initial Placement Gastrostomy Set
Cook Incorporated 510(k) NO: K170323(Traditional)
ATTN: Erum B. Nasir PHONE NO : 812 3353575 102607
450 Daniels Way, P.O. Box 489 SE DECISION MADE: 14-SEP-17
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile NS System
Jeil Medical Corporation 510(k) NO: K170368(Traditional)
ATTN: Seungyong Lee PHONE NO : 82 2 8503533
55 Digital-ro, 34-gil 702, 703, 70SE DECISION MADE: 11-SEP-17
Seoul KR 152-728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirLife Adult Heated Wire BiPAP/NIV Circuit
Vyaire Medical 510(k) NO: K170378(Traditional)
ATTN: Sharon Nichols PHONE NO : 847 3628107
75 North Fairway Drive SE DECISION MADE: 14-SEP-17
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini
Medtronic Advanced Energy 510(k) NO: K170381(Traditional)
ATTN: Heather Valley PHONE NO : 603 2945447
180 International Drive SE DECISION MADE: 07-SEP-17
Portsmouth NH 03801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
Topcon Medical Laser Systems, Inc.510(k) NO: K170409(Traditional)
ATTN: Sweta Srivastava PHONE NO : 925 2458300
606 Enterprise Court SE DECISION MADE: 12-SEP-17
Livermore CA 94550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Hemo-Force DVT Compression Sleeve
Medline Industries, Inc. 510(k) NO: K170415(Traditional)
ATTN: Matt Clausen PHONE NO : 847 6434785
Three Lakes Drive SE DECISION MADE: 08-SEP-17
Northfield IL 60093 510(k) STATEMENT
DEVICE: Glidewire GT
Terumo Corporation 510(k) NO: K170417(Traditional)
ATTN: Monika McDole-Russell PHONE NO : 732 3024900 4273
44-1, 2-Chome, Hatagaya SE DECISION MADE: 15-SEP-17
Shibuya-Ku, JP 151-0072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cranial Drill Bits and Accessories
Ad-Tech Medical Instrument Corpora510(k) NO: K170442(Traditional)
ATTN: Lisa Theama PHONE NO : 262 6341555
1901 William Street SE DECISION MADE: 07-SEP-17
Racine WI 53404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spider Frame External Fixation System
TASARIMMED TIBBI MAMULLER SANAYI V510(k) NO: K170482(Traditional)
ATTN: Sumru Alperen PHONE NO : 90 212 6742244
Demirkapi Topcular Mahallesi TopcuSE DECISION MADE: 27-SEP-17
Istanbul TR TR 34055 510(k) STATEMENT
DEVICE: Navina Classic System
Dentsply Sirona 510(k) NO: K170487(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, SuitSE DECISION MADE: 11-SEP-17
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gems Oocyte Retrieval Buffer ORB-20, ORB-50
Genea Biomedx Pty Ltd 510(k) NO: K170498(Traditional)
ATTN: Kea Dent PHONE NO : 61 2 84847677__
Level 2, 321 Kent Street SE DECISION MADE: 28-SEP-17
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SecurePortIV Catheter Securement Adhesive
Adhezion Biomedical, LLC 510(k) NO: K170505(Traditional)
ATTN: Richard G. Jones PHONE NO : 610 2417191
One Meridian Blvd - Suite 1B02 SE DECISION MADE: 29-SEP-17
Wyomissing PA 19610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phoenix Clinical ICON
Phoenix Technology Group, Inc. dba510(k) NO: K170527(Traditional)
ATTN: Christopher A. Henderson PHONE NO : 925 4625000
6630 Owens Drive SE DECISION MADE: 15-SEP-17
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Mesh Plate System
Arthrex, Inc. 510(k) NO: K170547(Traditional)
ATTN: Ivette Galmez PHONE NO : 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 01-SEP-17
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TN-Brush
GENOSS Co. Ltd. 510(k) NO: K170596(Traditional)
ATTN: Hyeyoung Moon PHONE NO : 82 70 70986316
1F, Gyeonggi R&DB Center, 105 GwanSE DECISION MADE: 11-SEP-17
Suwon-si KR 443-270 510(k) STATEMENT
DEVICE: Endoscope Sterilization Tray
Intuitive Surgical, Inc. 510(k) NO: K170640(Traditional)
ATTN: Kunal Gunjal PHONE NO : 408 5238017
1266 Kifer Road Building 101 SE DECISION MADE: 17-SEP-17
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
Intuitive Surgical, Inc. 510(k) NO: K170641(Traditional)
ATTN: Kunal Gunjal PHONE NO : 408 5238017
1266 Kifer Road, Building 101 SE DECISION MADE: 21-SEP-17
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
Intuitive Surgical, Inc. 510(k) NO: K170644(Traditional)
ATTN: Kunal Gunjal PHONE NO : 408 5238017
1266 Kifer Road SE DECISION MADE: 11-SEP-17
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Xi EndoWrist Instruments and Accessories
Intuitive Surgical, Inc. 510(k) NO: K170645(Traditional)
ATTN: Kunal Gunjal PHONE NO : 408 5238017
1266 Kifer Road SE DECISION MADE: 11-SEP-17
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Locking Pediatric Osteotomy Plate (LolliPOP) System
Pega Medical Inc. 510(k) NO: K170704(Traditional)
ATTN: Ariel R. Dujovne PHONE NO : 450 6885144
1111 Autoroute Chomedey SE DECISION MADE: 08-SEP-17
Iaval CA H7W 5J8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX Wrist System
Jeil Medical Corporation 510(k) NO: K170705(Traditional)
ATTN: Ji won SONG PHONE NO : 82 2 8503587
SE DECISION MADE: 21-SEP-17
Seoul KR 152-728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermage FLX System and Accessories
Solta Medical 510(k) NO: K170758(Traditional)
ATTN: Melissa Thomas PHONE NO : 510 2595299
11720 North Creek Pkwy N., Suite 1SE DECISION MADE: 22-SEP-17
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAUMACEM™ V+ Injectable Bone Cement
Synthes (USA) Products, LLC 510(k) NO: K170802(Traditional)
ATTN: Christopher J. Medberry PHONE NO : 1 610 7196806
1301 Goshen Parkway SE DECISION MADE: 28-SEP-17
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOFOS
CRYOFOS Medical Gmbh 510(k) NO: K170810(Traditional)
ATTN: Gerlinde Hornung-Stehling PHONE NO : 49 0 7212039933
Lammstrasse 21 SE DECISION MADE: 27-SEP-17
Karlsruhe DE 76133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
Brainlab AG 510(k) NO: K170816(Traditional)
ATTN: Rainer Birkenbach PHONE NO : 49 899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 26-SEP-17
Munchen DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Caries Detector
Ortek Therapeutics, Inc. 510(k) NO: K170822(Traditional)
ATTN: Mitchell Goldberg PHONE NO : 516 4844500
4 Expressway Plaza SE DECISION MADE: 11-SEP-17
Roslyn Heights NY 11577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medentika CAD/CAM TiBases
Medentika GmbH 510(k) NO: K170838(Traditional)
ATTN: Gerhard Polzer PHONE NO : 49 07 229699120
AHammweg 8-10 SE DECISION MADE: 15-SEP-17
Huegelsheim DE 76549 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
Instrumentation Laboratory Co. 510(k) NO: K170854(Traditional)
ATTN: Carol Marble PHONE NO : 781 8614467
180 Hartwell Road SE DECISION MADE: 08-SEP-17
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-Rex Standalone ALIF
SIATS, LLC 510(k) NO: K170855(Traditional)
ATTN: Robert Compton PHONE NO : 918 9952090
6316 E 102nd Street SE DECISION MADE: 07-SEP-17
Tulsa OK 74137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories
Intuitive Surgical, Inc. 510(k) NO: K170875(Traditional)
ATTN: Manjunath Bisalehalli PHONE NO : 408 5237089
1266 Kifer Road, Building 101 SE DECISION MADE: 12-SEP-17
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
Intuitive Surgical, Inc. 510(k) NO: K170879(Traditional)
ATTN: Kunal Gunjal PHONE NO : 408 5238017
1266 Kifer Road Building 101 SE DECISION MADE: 21-SEP-17
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIPER PRIME navigated inserter
Medos International, SARL 510(k) NO: K170937(Traditional)
ATTN: Karen Sylvia PHONE NO : 508 9773804
Chemin-Blanc 38 SE DECISION MADE: 14-SEP-17
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System
STERIS Corporation 510(k) NO: K170956(Traditional)
ATTN: Tricia Cregger PHONE NO : 440 3927189
5960 Heisley Rd SE DECISION MADE: 22-SEP-17
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epilaser
Epilady 2000 LLC 510(k) NO: K170970(Traditional)
ATTN: Joseph Miller PHONE NO : 972 4 6860400
3 Hacharash St. Ind. Zone SE DECISION MADE: 01-SEP-17
Hazor Haglilit IL 1035102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroQuant
CorTechs Labs, Inc 510(k) NO: K170981(Traditional)
ATTN: Kora Marinkovic PHONE NO : 858 4599700
4690 Executive Drive, Suite 250 SE DECISION MADE: 07-SEP-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Urbanek Device
TMJ Services, LLC 510(k) NO: K170985(Traditional)
ATTN: Anthony Urbanek PHONE NO : 615 7712189
2009 Mallory Lane SE DECISION MADE: 25-SEP-17
Franklin TN 37067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentis Dental Implant System
Dentis Co.,Ltd. 510(k) NO: K171027(Traditional)
ATTN: Sun Chul Shin PHONE NO : 82 53 5822804
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 06-SEP-17
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Katalyst Mark 1 Muscle Stimulation System
Katalyst Inc. 510(k) NO: K171035(Traditional)
ATTN: Amish Patel PHONE NO : 406 6163671
316 Occidental Ave. South B300 SE DECISION MADE: 06-SEP-17
Seattle WA 98104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZON Therapy System
Magstim Company Ltd. 510(k) NO: K171051(Traditional)
ATTN: Tom Campbell PHONE NO : 44 019 94240798
Spring Gardens SE DECISION MADE: 13-SEP-17
Whitland GB SA34 0HR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVISION Total Ankle Revision System
Wright Medical Technology, Inc. 510(k) NO: K171067(Traditional)
ATTN: Val Myles PHONE NO : 901 2905162
1023 Cherry Road SE DECISION MADE: 11-SEP-17
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K171107(Traditional)
ATTN: Julie Bassett PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 26-SEP-17
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carefusion NeutraClear Needle-free connector (EL-NC1000)
Cair L.G.L 510(k) NO: K171117(Traditional)
ATTN: Delphine Molinari PHONE NO : 33 0 478437707
1, Allee des Chevreuils - Parc terSE DECISION MADE: 01-SEP-17
Lissieu FR 69380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leksell Vantage Stereotactic System
Elekta Instrument AB 510(k) NO: K171123(Traditional)
ATTN: Matilda Forsberg PHONE NO : 011 468 58725400
Kungstensgatan 18 SE DECISION MADE: 15-SEP-17
Stockholm SE 10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Implantium II
Dentium Co., Ltd. 510(k) NO: K171126(Abbreviated)
ATTN: Yoon Spyoon PHONE NO : 82 312 072200
150, Eondong-ro Giheung-gu SE DECISION MADE: 07-SEP-17
Yongin-si KR 443-270 510(k) STATEMENT
DEVICE: Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel
Medbio LLC. 510(k) NO: K171144(Traditional)
ATTN: Jatin Rajani PHONE NO : 954 5331826
4846 Citrus Way SE DECISION MADE: 12-SEP-17
Cooper City FL 33330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)
Dimensional Bioceramics LLC 510(k) NO: K171161(Traditional)
ATTN: David Delaney PHONE NO : 831 2344892
163 McKenzie Creek Road SE DECISION MADE: 25-SEP-17
Scotts Valley CA 95066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-CATH Microcatheter
Acrostak (Schweiz) AG 510(k) NO: K171176(Traditional)
ATTN: Carmen Herraez PHONE NO : 41 52 2339551
Stegackerstrasse 14 SE DECISION MADE: 15-SEP-17
Winterthur CH 8409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Central Monitoring System
Edan Instruments, Inc. 510(k) NO: K171178(Traditional)
ATTN: Alice Yang PHONE NO : 86 755 26858736
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 06-SEP-17
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Persyst Mobile App
Persyst Development Corporation 510(k) NO: K171184(Traditional)
ATTN: Dari Darabbeigi PHONE NO : 858 4614542 109
420 Stevens Avenue Suite 210 SE DECISION MADE: 21-SEP-17
Solana Beach CA 92075 510(k) STATEMENT
DEVICE: AIR-FLOW PLUS Prophylaxis powder
E.M.S. Electro Medical Systems S.A510(k) NO: K171189(Traditional)
ATTN: Suzanne Fassio-Hardy PHONE NO : 41 229 944700
Chemin de la Vuarpilliere 31 SE DECISION MADE: 11-SEP-17
Nyon CH ch-1260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuViz Prime Multi-slice CT Scanner System
Neusoft Medical Systems Co., Ltd. 510(k) NO: K171201(Traditional)
ATTN: Shao Xiancheng PHONE NO : 86 24 83660645
No. 16, Shiji Road Hunnan IndustriSE DECISION MADE: 13-SEP-17
Shenyang CN 110179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OIC External Fixation System
Orthopaedic Implant Company 510(k) NO: K171211(Traditional)
ATTN: Douglas Fulton PHONE NO : 775 6368281
770 Smithridge Dr. #400 SE DECISION MADE: 27-SEP-17
Reno NV 89502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirFit N20
ResMed Ltd 510(k) NO: K171212(Traditional)
ATTN: Kim Kuan LEE PHONE NO : 61 2 88841000
1 Elizabeth Macarthur Drive SE DECISION MADE: 28-SEP-17
Bella Vista AU 2153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QiF Blood and Fluid Warmer
Quality In Flow Ltd. 510(k) NO: K171215(Traditional)
ATTN: Neta Sherman PHONE NO : 972 54 6600146
Kibutz Einat POB 29 SE DECISION MADE: 27-SEP-17
Kibutz Einat IL 4880500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PeriView FLEX
Olympus Surgical Technologies Amer510(k) NO: K171232(Traditional)
ATTN: Mary Anne Patella PHONE NO : 508 8042600
136 Turnpike Road SE DECISION MADE: 21-SEP-17
Southborough MA 01772-2104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Shenzhen Mindray Bio-Meidcal Elect510(k) NO: K171233(Traditional)
ATTN: Zhai Pei PHONE NO : 0086 0755 81885604
Mindray Building, Keji 12th Road SSE DECISION MADE: 12-SEP-17
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 014 Hydrophilic Coated PTA Balloon Dilatation Catheter
Creagh Medical 510(k) NO: K171251(Traditional)
ATTN: Shane Costello PHONE NO : 00353 90 9646300
IDA Business Park SE DECISION MADE: 08-SEP-17
Ballinasloe IE H53 K8P4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TempSure
Cynosure, Inc 510(k) NO: K171262(Traditional)
ATTN: Amy Tannenbaum PHONE NO : 781 9932454
5 Carlisle Road SE DECISION MADE: 22-SEP-17
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
University of Texas Medical School510(k) NO: K171303(Traditional)
ATTN: K. Lance Gould PHONE NO : 713 5006611
6431 Fannin St. Room 4.256 MSB SE DECISION MADE: 22-SEP-17
Houston TX 77030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BR-FHUS Navigation 1.0
TaiHao Medical Inc. 510(k) NO: K171309(Traditional)
ATTN: Hsin Hung Lai PHONE NO : 886 227 365679
3F.-8, No.100, Sec. 2 Heping E. RdSE DECISION MADE: 29-SEP-17
Taipei TW 10663 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear Vinyl Powder-free Patient Examination Gloves
Shandong Zhi Hong Medical Products510(k) NO: K171317(Traditional)
ATTN: Jennifer Guo PHONE NO : 86 189 53331678
231 Dongqi Industrial Park SE DECISION MADE: 11-SEP-17
Qingzhou CN 255000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPHOTAS CELLUMA3
Biophotas Inc 510(k) NO: K171323(Traditional)
ATTN: PATRICK JOHNSON PHONE NO : 714 8381956
1000 E. Howell Ave. Ste A SE DECISION MADE: 01-SEP-17
Anaheim CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nanova Sealant
Nanova Biomaterials Inc 510(k) NO: K171330(Traditional)
ATTN: Andrew C. Ritts PHONE NO : 573 8756682
3806 Mojave Ct SE DECISION MADE: 08-SEP-17
Columbia MO 65202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indego
Parker Hannifin Corporation 510(k) NO: K171334(Traditional)
ATTN: Achilleas Dorotheou PHONE NO : 216 8962044
1390 E. Highland Road SE DECISION MADE: 08-SEP-17
Macedonia OH 44056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Posterior Spine Truss System (PSTS) Interbody Fusion Device
4Web, Inc. 510(k) NO: K171351(Traditional)
ATTN: Jessee Hunt PHONE NO : 800 2857090
6170 REsearch Rd., Suite 219 SE DECISION MADE: 08-SEP-17
Frisco TX 75033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Emprint SX Ablation Platform and Accessories
Coviden llc 510(k) NO: K171358(Traditional)
ATTN: Patti Arndt PHONE NO : 303 5816668
5920 Longbow Dr. SE DECISION MADE: 01-SEP-17
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pollogen Legend+ System
Pollogen Ltd. 510(k) NO: K171359(Traditional)
ATTN: Ilana Dessow Lironne PHONE NO : 972 3 5104110
6 Kaufman St. SE DECISION MADE: 13-SEP-17
Tel Aviv IL 6801298 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
SEMPERIT INVESTMENTS ASIA PTE. LTD510(k) NO: K171378(Traditional)
ATTN: Clemens Eichler PHONE NO : 65 62 744861
8 Jurong Town Hall Road, #29-03 ToSE DECISION MADE: 14-SEP-17
Singapore SG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carbon Monoxide Breath Sensor System (COBSS)
Carrot Sense, Inc. 510(k) NO: K171408(Traditional)
ATTN: Daniel J. Balbierz PHONE NO : 650 5203259
1600 Seaport Blvd, Suite 150 SE DECISION MADE: 29-SEP-17
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Berkeley VC-10 Vacuum Curettage System
Gyrus ACMI 510(k) NO: K171440(Special)
ATTN: Christina Flores PHONE NO : 508 8042776
136 Turnpike Rd SE DECISION MADE: 29-SEP-17
Southborough MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exofin Fusion Skin Closure System
Chemence Medical, Inc. 510(k) NO: K171442(Abbreviated)
ATTN: Kenneth Broadley PHONE NO : 678 6890761
200 Technology Drive SE DECISION MADE: 25-SEP-17
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cefaly Acute
CEFALY Technology 510(k) NO: K171446(Traditional)
ATTN: Jean-Yves Mignolet PHONE NO : 32 4 3676722
Rue Louis Plescia 34 SE DECISION MADE: 15-SEP-17
Seraing BE 4102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder-free Clear Vinyl Patient Examination Gloves
Shandong Zhiwei Medical Products, 510(k) NO: K171460(Traditional)
ATTN: Carrie Wu PHONE NO : 86 83 174088
No. 4519 Qingzhou Road SE DECISION MADE: 24-SEP-17
Qingzhou CN 255000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASPIRE Bellus II
FUJIFILM Medical Systems U.S.A., I510(k) NO: K171463(Traditional)
ATTN: Jyh-Shyan Lin PHONE NO : 301 2511092
419 West Avenue SE DECISION MADE: 29-SEP-17
Stamford CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tritanium C Anterior Cervical Cage
STRYKER SPINE 510(k) NO: K171496(Traditional)
ATTN: Deborah Cynamon PHONE NO : 201 7498388
2 Pearl Court SE DECISION MADE: 06-SEP-17
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Occlusion Detection Dressing Kit
Cardinal Health 510(k) NO: K171499(Traditional)
ATTN: Beth Foster PHONE NO : 847 8872325
1500 S Waukegan Rd SE DECISION MADE: 22-SEP-17
Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CustomizedBone Service
Fin-ceramica faenza spa 510(k) NO: K171507(Traditional)
ATTN: Marina Monticelli PHONE NO : 0039 054 6607311
via ravegnana 186 SE DECISION MADE: 01-SEP-17
Faenza IT 48018 510(k) STATEMENT
DEVICE: Footmotion Plating System
Newclip Technics 510(k) NO: K171510(Special)
ATTN: Gaelle Lussori PHONE NO : 33 228 213712
PA de la Lande Saint Martin - 45 rSE DECISION MADE: 08-SEP-17
Haute-Goulaine FR 44 115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLXfit™
Expanding Orthopedics, Inc. 510(k) NO: K171519(Traditional)
ATTN: Ofer Bokobza PHONE NO : 404 4799926
3379 Peachtree Road NE (Buckhead),SE DECISION MADE: 15-SEP-17
Atlanta GA 30326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
CareFusion 510(k) NO: K171531(Traditional)
ATTN: Tamara Brey PHONE NO : 847 3629485
75 North Fairway Drive SE DECISION MADE: 11-SEP-17
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPI 3 Hb A1c
Sebia 510(k) NO: K171537(Traditional)
ATTN: Karen Aderson PHONE NO : 770 4463707 3704
1705 Corporate Drive Suite 400 SE DECISION MADE: 12-SEP-17
Norcross GA 30093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Orange)
Comfort Rubber Gloves Industries S510(k) NO: K171541(Traditional)
ATTN: Chan Yew Men PHONE NO : 605 8472777
Lot 821, Jalan Matang SE DECISION MADE: 20-SEP-17
Matang MY 34750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExsoMed ITN Cannulated Screw System
Exsomed Holdings Company, LLC 510(k) NO: K171558(Traditional)
ATTN: Richard Kovach PHONE NO : 602 4663186
7227 N 16th Street, Suite 245 SE DECISION MADE: 01-SEP-17
Phoenix AZ 85020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEO Pedicle Screw System™
Neo Medical S.A. 510(k) NO: K171582(Traditional)
ATTN: Jonas Larsson PHONE NO : 41 225 483880
Route de Lausanne 157A SE DECISION MADE: 12-SEP-17
Villette (Lavaux) CH 1096 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RhythmView Workstation
Abbott Electrophysiology 510(k) NO: K171583(Traditional)
ATTN: Dennis Pozzo PHONE NO : 214 3006580
1530 Obrien Drive, Suite B SE DECISION MADE: 01-SEP-17
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WiTouch Pro, WiTouch, Neubac
Hollywog LLC 510(k) NO: K171599(Traditional)
ATTN: Michael Treas PHONE NO : 423 3057778 108
2830 Amnicola Highway SE DECISION MADE: 22-SEP-17
Chattanooga TN 37406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Xi Surgical System
Intuitive Surgical, Inc 510(k) NO: K171632(Traditional)
ATTN: Brandon Hansen PHONE NO : 408 5232100
1266 Kifer Road SE DECISION MADE: 19-SEP-17
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive TLX Interbody System
NuVasive, Incorporated 510(k) NO: K171633(Traditional)
ATTN: Cynthia Adams PHONE NO : 858 3204549
7475 Lusk Blvd. SE DECISION MADE: 28-SEP-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BM.IRIS
Bluecore Co.,Ltd. 510(k) NO: K171648(Traditional)
ATTN: Bill Choi PHONE NO : 82 51 7474318
Acehigh 21, 48 Centum-Jungang ro 1SE DECISION MADE: 08-SEP-17
Haeundae-gu KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fresenius Liberty Select Cycler
Fresenius Medical Care Renal Thera510(k) NO: K171652(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 6994479
920 Winter Street SE DECISION MADE: 15-SEP-17
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scopis Extended Instrument Set EM
Scopis GmbH 510(k) NO: K171661(Traditional)
ATTN: Christopher Özbek PHONE NO : 49 302 0169380
Heinrich-Heine-Platz 10 SE DECISION MADE: 27-SEP-17
Berlin DE 10719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
Bio-Rad Laboratories, Inc. 510(k) NO: K171664(Special)
ATTN: Sweta Patel PHONE NO : 510 7415157
4000 Alfred Nobel Drive SE DECISION MADE: 13-SEP-17
Hercules CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Glove
Professional Latex Sdn Bhd 510(k) NO: K171667(Traditional)
ATTN: Yoon Lim Kok PHONE NO : 605 89 11637
Lot 52, Jalan Logam 2, Kamunting RSE DECISION MADE: 08-SEP-17
Kamunting MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Med4 Elite
Cool Systems, Inc. (dba Game Ready510(k) NO: K171685(Traditional)
ATTN: Natalie Kennel PHONE NO : 510 9845351
1800 Sutter Street, Suite 500 SE DECISION MADE: 29-SEP-17
Concord CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
Choice Spine 510(k) NO: K171686(Traditional)
ATTN: Kim Finch PHONE NO : 865 2433375
400 Erin Drive SE DECISION MADE: 15-SEP-17
Knoxville TN 37924 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Relieva SpinPlus Nav Balloon Sinuplasty System
Acclarent, Inc. 510(k) NO: K171687(Traditional)
ATTN: James Patrick Garvey II PHONE NO : 949 7898505
33 Technology Drive SE DECISION MADE: 05-SEP-17
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CuffLink Implant System
CONMED Corporation 510(k) NO: K171725(Traditional)
ATTN: Dionne Sanders PHONE NO : 727 3995564
525 French Road SE DECISION MADE: 08-SEP-17
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LapBag
Sejong Medical Co., Ltd. 510(k) NO: K171726(Traditional)
ATTN: Yoojung Choi PHONE NO :
11, Sinchon 2-ro SE DECISION MADE: 25-SEP-17
Paju-si KR 10880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm
Sterngold Dental, LLC 510(k) NO: K171728(Abbreviated)
ATTN: Maria Rao PHONE NO : 508 2265660
23 Frank Mossberg Drive SE DECISION MADE: 28-SEP-17
Attleboro MA 02703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FuckWater
Non-Friction Products Inc. 510(k) NO: K171730(Traditional)
ATTN: Marc Barrette PHONE NO : 416 8171745
551 Church Street SE DECISION MADE: 07-SEP-17
Toronto CA M4Y 2E2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas Cdiff Nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc. 510(k) NO: K171770(Traditional)
ATTN: Clare Santulli PHONE NO : 925 7308886
4300 Hacienda Drive SE DECISION MADE: 12-SEP-17
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WowGoHealth Blood Glucose Monitoring System
Biotest Medical Corporation 510(k) NO: K171785(Special)
ATTN: Fred Lee PHONE NO : 886 4 25326668 413
No. 3-2, Chien-kuo Rd., TEPZ TantzSE DECISION MADE: 15-SEP-17
Taichung TW 42760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
Alere Scarborough, Inc. 510(k) NO: K171792(Traditional)
ATTN: Angela Drysdale PHONE NO : 207 4151393
10 Southgate Road SE DECISION MADE: 29-SEP-17
Scarborough ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thommen Implant System
Thommen Medical AG 510(k) NO: K171795(Traditional)
ATTN: Daniel Snetivy PHONE NO : 41 61 9659020
Neckarsulmstrasse 28 SE DECISION MADE: 29-SEP-17
Grenchen CH 2540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zap-X Radiosurgery System
Zap Surgical Systems 510(k) NO: K171804(Traditional)
ATTN: Radhika Mohan Bodduluri PHONE NO : 650 7965302
590 Taylor Way Suite A SE DECISION MADE: 21-SEP-17
San Carlos CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml
ConceptoMed AS 510(k) NO: K171805(Special)
ATTN: Marit Martinsen PHONE NO : 47 951 00720
Hattvikveien 2 SE DECISION MADE: 08-SEP-17
Ballstad NO N-8373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
Biotest Medical Corporation 510(k) NO: K171822(Special)
ATTN: Fred Lee PHONE NO : 866 4 25326668 413
No. 3-2, Chien-kuo Rd., TEPZ TantzSE DECISION MADE: 20-SEP-17
Taichung TW 42760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoNaut
Therenva SAS 510(k) NO: K171829(Traditional)
ATTN: Matthis HAMY PHONE NO : 33 2 99283751
4 rue Jean Jaures SE DECISION MADE: 21-SEP-17
Rennes FR 35000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Range/Denali/Mesa Spinal System
K2M, Inc. 510(k) NO: K171832(Traditional)
ATTN: Nancy Giezen PHONE NO : 571 9192000
600 Hope Parkway SE SE DECISION MADE: 14-SEP-17
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Consolidated Operating Room Equipment (CORE) 2 Console
Stryker Corporation 510(k) NO: K171840(Traditional)
ATTN: Nicholas Werner PHONE NO : 269 3892971
4100 E. Milham Ave. SE DECISION MADE: 15-SEP-17
Kalamazoo MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DARCO Locking Bone Plate System
Wright Medical Technology, Inc. 510(k) NO: K171852(Traditional)
ATTN: Val Myles PHONE NO : 901 2905162
1023 Cherry Road SE DECISION MADE: 21-SEP-17
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALAXY G3 Mini Microcoil Delivery System
Codman & Shurtleff, Inc 510(k) NO: K171862(Traditional)
ATTN: Yoon Hee Beatty PHONE NO : 305 2652919
325 Paramount Drive SE DECISION MADE: 25-SEP-17
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceramill Zolid HT+ white
Amann Girrbach AG 510(k) NO: K171876(Traditional)
ATTN: Debora Engel PHONE NO : 49 7231 957260
Herrschaftswiesen 1 SE DECISION MADE: 20-SEP-17
Koblach AT 6842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZS3 Ultrasound System, z.one pro Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K171891(Traditional)
ATTN: Zhai Pei PHONE NO : 86 075 581885604
Mindray Building, Keji 12th Road SSE DECISION MADE: 21-SEP-17
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)
Bluestone Synergy 510(k) NO: K171893(Traditional)
ATTN: Lisa Peterson PHONE NO : 512 5070746
5520 Ventana Ct. SE DECISION MADE: 08-SEP-17
Pueblo CO 81005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive® Precept™ Spinal System
NuVasive, Incorporated 510(k) NO: K171894(Traditional)
ATTN: Marysa Loustalot PHONE NO : 858 3204515
7475 Lusk Blvd. SE DECISION MADE: 28-SEP-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anatotemp Anatomic Dental Implant Healing Abutment
Buckeye Medical Technologies LLC 510(k) NO: K171922(Traditional)
ATTN: Terry B. Philibin PHONE NO : 330 7199868
405 Niles Cortland Rd SE Ste 202 SE DECISION MADE: 28-SEP-17
Warren OH 44484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peerbridge Cor(TM) System
Peerbridge Health INc. 510(k) NO: K171936(Third Party - Traditional)
ATTN: Arthur A. Bertolero PHONE NO : 925 2602096
1440 Broadway, 23rd Floor SE DECISION MADE: 27-SEP-17
New York NY 10018 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FreeStyle Precision Neo Blood Glucose Test Strips
Abbott Diabetes Care Inc. 510(k) NO: K171941(Traditional)
ATTN: Danielle Tayor PHONE NO : 510 2392674
1360 South Loop Road SE DECISION MADE: 27-SEP-17
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrocardiograph
Edan Instruments, Inc. 510(k) NO: K171943(Traditional)
ATTN: Alice Yang PHONE NO : 86 755 26858736
#15 Jinhui Road,Jinsha Community, SE DECISION MADE: 25-SEP-17
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bard Mission Disposable Core Biopsy Instrument
Bard Peripheral Vascular, Inc. 510(k) NO: K171953(Third Party - Traditional)
ATTN: Susan Sheffield PHONE NO : 480 3506067
1625 W 3rd St. SE DECISION MADE: 14-SEP-17
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
Hologic, Inc. 510(k) NO: K171963(Traditional)
ATTN: Ron Domingo PHONE NO : 858 4108167
10210 Genetic Center Drive SE DECISION MADE: 26-SEP-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LigaMetrics Suture Anchors
Mortise Medical LLC 510(k) NO: K171964(Traditional)
ATTN: Robert Hoy PHONE NO : 614 4486358
124 South 600 West, Suite 100 SE DECISION MADE: 19-SEP-17
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resection Electrodes with HF cable
Olympus Winter & Ibe GmbH 510(k) NO: K171965(Traditional)
ATTN: Jan-Oliver Upmeier PHONE NO : 49 406 69662098
Kuehnstrasse 61 SE DECISION MADE: 28-SEP-17
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterling Supreme Diode Laser
CAO Group, Inc. 510(k) NO: K171986(Traditional)
ATTN: Robert K. Larsen PHONE NO : 1 801 2569282
4628 West Skyhawk Drive SE DECISION MADE: 22-SEP-17
West Jordan UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sculpsure
Cynosure, Inc 510(k) NO: K171992(Traditional)
ATTN: Amy Tannenbaum PHONE NO : 781 9932454
5 Carlisle Road SE DECISION MADE: 26-SEP-17
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
Careglove Global Sdn Bhd 510(k) NO: K172015(Traditional)
ATTN: Lim Kwee Shyan PHONE NO : 60 6 6782377
Lot 17479, Lrg Senawang 3/2, Off JSE DECISION MADE: 26-SEP-17
Seremban MY 70450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FluidSmart
THERMEDX, LLC 510(k) NO: K172048(Special)
ATTN: Homer Gregory PHONE NO : 1 440 5420883
31200 Solon Rd., Unit #1 SE DECISION MADE: 05-SEP-17
Solon OH 44139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ti-Diagon Oblique TLIF
Camber Spine Technologies 510(k) NO: K172064(Traditional)
ATTN: Daniel Pontecorvo PHONE NO : 484 4277060
418 E. Lancaster Avenue SE DECISION MADE: 15-SEP-17
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCARLET AC-T
SPINEART 510(k) NO: K172065(Traditional)
ATTN: Franck PENNESI PHONE NO : 41 22 5701200
3 chemin du pre Fleuri SE DECISION MADE: 29-SEP-17
Plan Les Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Photoelectric Therapy System
Xstrahl Ltd. 510(k) NO: K172080(Traditional)
ATTN: Andrew Mullen PHONE NO : 11 44 1543688920
Unit 2 Maybrook Industrial Estate,SE DECISION MADE: 29-SEP-17
Brownhills GB WS8 7DG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S60 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp. 510(k) NO: K172082(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
4/f, 5/f, 8/f, 9/f & 10/f Yizhe buSE DECISION MADE: 21-SEP-17
Shenzhen CN 518051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Matira™ Anterior Cervical System
Kalitec Direct, LLC 510(k) NO: K172086(Traditional)
ATTN: Keith Cannan PHONE NO : 407 5452063 103
618 E. South Street, Suite 500 SE DECISION MADE: 22-SEP-17
Orlando FL 32801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROMEO® 2 Posterior Osteosynthesis System
Spineart 510(k) NO: K172101(Traditional)
ATTN: Franck Pennesi PHONE NO : 41 22 5701200
3 chemin du pre Fleuri SE DECISION MADE: 26-SEP-17
Plan Les Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
Liofilchem s. r. l. 510(k) NO: K172109(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 0858930745
Via Scozia zona ind.le SE DECISION MADE: 27-SEP-17
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: Prelude Pursuit Splittable Sheath Introducer
Merit Medical Systems, Inc. 510(k) NO: K172117(Traditional)
ATTN: Jacquelyn Huyghue PHONE NO : 610 6515090
65 Great Valley Parkway SE DECISION MADE: 11-SEP-17
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Veress Needle
WickiMed (Huizhou) Medical Equipme510(k) NO: K172120(Traditional)
ATTN: Haobin Li PHONE NO : 0086 0752 3860807
Tang Jiao Wang Street, Lilin Town,SE DECISION MADE: 14-SEP-17
Huizhou CN 516000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert Xpress Strep A
Cepheid 510(k) NO: K172126(Traditional)
ATTN: Yi-Ping Lin PHONE NO : 408 4006838
904 Caribbean Drive SE DECISION MADE: 25-SEP-17
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FibroScan 430 Mini+
Echosens 510(k) NO: K172142(Traditional)
ATTN: Karine Bonenfant PHONE NO : 33 144 827856
30 Place d'Italie SE DECISION MADE: 13-SEP-17
Paris FR 75013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
bioMerieux, Inc 510(k) NO: K172150(Traditional)
ATTN: Cherece L. Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 15-SEP-17
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS(R) Wrist 2.5 System
Medartis AG 510(k) NO: K172170(Traditional)
ATTN: Andrea Schweizer PHONE NO : 41 61 6333434
Hochbergerstrasse 60E SE DECISION MADE: 08-SEP-17
Basel CH CH-4057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECOM™ Cardiac Output Monitoring System
ECOM Medical, Inc 510(k) NO: K172196(Traditional)
ATTN: Guy Lowery PHONE NO : 1 949 4291390
27127 Calle Arroyo, Suite 1905 SE DECISION MADE: 19-SEP-17
San Juan Capistrano CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
Medtronic Sofamor Danek 510(k) NO: K172199(Traditional)
ATTN: Justin O'Connor PHONE NO : 901 3463133
1800 Pyramid Place SE DECISION MADE: 19-SEP-17
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mako Total Knee Application
MAKO Surgical Corp. 510(k) NO: K172219(Traditional)
ATTN: Karen Ariemma PHONE NO : 201 8315718
2555 Davie Road SE DECISION MADE: 21-SEP-17
Fort Lauderdale FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magic3 Go Intermittent Urinary Catheter
C.R. Bard, Inc. 510(k) NO: K172247(Traditional)
ATTN: Nancy Underwood PHONE NO : 770 7846284
8195 Industrial Blvd SE DECISION MADE: 20-SEP-17
Covington GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitality® Spinal Fixation System, Vitality®+ Power Instrument System
Zimmer Biomet Spine, Inc. 510(k) NO: K172275(Traditional)
ATTN: Kelly Stratton PHONE NO : 303 5018386
10225 Westmoor Drive SE DECISION MADE: 27-SEP-17
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMT Posterior Fixation System
Providence Medical Technology, Inc510(k) NO: K172279(Traditional)
ATTN: Edward Liou PHONE NO : 1 415 9239376
1331 N. California Blvd. Suite 320SE DECISION MADE: 20-SEP-17
Walnut Creek CA 94596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accordion Piccolo Stone Management Device
THS International, Inc. d/b/a Acco510(k) NO: K172299(Special)
ATTN: David Quigley PHONE NO : 317 7592869
9465 Counselors Row, Suite 200 SE DECISION MADE: 19-SEP-17
Indianapolis IN 46240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoscopic Ultrasound Aspiration Needle
Micro-Tech (Nanjing) CO.,Ltd. 510(k) NO: K172309(Traditional)
ATTN: Becky Li PHONE NO : 86 25 58646378
No. 10 Gaoke Third Road SE DECISION MADE: 29-SEP-17
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
Art Optical Contact Lens Inc 510(k) NO: K172314(Traditional)
ATTN: Mike Johnson PHONE NO : 616 5595167
3175 3 Mile Rd NW SE DECISION MADE: 20-SEP-17
Grand Rapids MI 49534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voluson E6, Voluson E8, Voluson E10
GE Healthcare 510(k) NO: K172342(Traditional)
ATTN: Bryan Behn PHONE NO : 414 7214214
9900 Innovation Drive, Milwaukee CSE DECISION MADE: 29-SEP-17
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BladderScan Prime PLUS System
Verathon Incorporated 510(k) NO: K172356(Third Party - Traditional)
ATTN: Swapna Chirala PHONE NO : 425 6295582
20001 North Creek Parkway SE DECISION MADE: 15-SEP-17
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QuadraSphere Microspheres
Biosphere Medical, S.A. 510(k) NO: K172372(Special)
ATTN: Alix Fonlladosa PHONE NO : 33 1 48172529
Parc des Nations – Paris Nord 2, 3SE DECISION MADE: 06-SEP-17
Roissy en France FR 95700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroSTAAR Injector System Cartridges
STAAR Surgical Company 510(k) NO: K172375(Special)
ATTN: Kate Ueda PHONE NO : 626 3037902 2316
1911 Walker Avenue SE DECISION MADE: 06-SEP-17
Monrovia CA 91016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U2 Diagnostic Ultrasound System
Edan Instruments Inc 510(k) NO: K172380(Traditional)
ATTN: Alice Yang PHONE NO : 86 7552 6858736
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 29-SEP-17
Shenzhen CN 518067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clarius Ultrasound System
Clarius Mobile Health Corp. 510(k) NO: K172385(Third Party - Abbreviated)
ATTN: Abhijit Ahir PHONE NO : 778 2609975
350 - 3605 Gilmore Way SE DECISION MADE: 14-SEP-17
Burnaby CA V5G 4X5 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Steerable Guide Catheter
Abbott Vascular 510(k) NO: K172394(Special)
ATTN: Makena Mc Gowan PHONE NO : 408 8450937
3200 Lakeside Drive SE DECISION MADE: 06-SEP-17
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sherlock 3CG Tip Positioning System Stylet
C.R. Bard, Inc. 510(k) NO: K172397(Special)
ATTN: Mona Shahrebani PHONE NO : 1 801 5225967
605 North 5600 West SE DECISION MADE: 29-SEP-17
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
Wear Safe (Malaysia) Sdn. Bhd. 510(k) NO: K172420(Traditional)
ATTN: Cho Sow Fong PHONE NO : 603 3392 1388 1328
LOT 5068 & 5069, BATU 4 1/2, JALANSE DECISION MADE: 29-SEP-17
Klang MY 41050 510(k) STATEMENT
DEVICE: NICO BrainPath
NICO Corporation 510(k) NO: K172433(Special)
ATTN: Sean Spence PHONE NO : 317 6607118
250 E 96TH St. Suite 125 SE DECISION MADE: 07-SEP-17
Indianapolis IN 46240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amsel Occluder Device
Amsel Medical 510(k) NO: K172479(Special)
ATTN: Raanan Miller PHONE NO : 617 3082304
171 Hamilton Street SE DECISION MADE: 14-SEP-17
Cambridge MA 02139 510(k) STATEMENT
DEVICE: IntelliCart System
Dornoch Medical Systems 510(k) NO: K172481(Special)
ATTN: Larry Smith PHONE NO : 816 5954416
200 North West Parkway SE DECISION MADE: 14-SEP-17
Riverside MO 64150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle
Anexa Biomedical, Inc. 510(k) NO: K172486(Traditional)
ATTN: Lenny Budloo PHONE NO : 813 7807927
40423 Air Time Avenue SE DECISION MADE: 21-SEP-17
Zephyrhills FL 33542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reliance Cervical IBF System
Reliance Medical Systems, LLC 510(k) NO: K172489(Special)
ATTN: Bret M. Berry PHONE NO : 801 2953280
545 West 500 South, Suite 100 SE DECISION MADE: 07-SEP-17
Bountiful UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iNSitu Total Hip System
Theken Companies, LLC 510(k) NO: K172501(Special)
ATTN: Dale Davison PHONE NO : 330 7337600
1800 Triplett Blvd SE DECISION MADE: 21-SEP-17
Akron OH 44306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Cathena Safety IV Catheter
Becton, Dickinson and Company 510(k) NO: K172506(Third Party - Traditional)
ATTN: Henry Boland PHONE NO : 801 5652300
9450 South State Street SE DECISION MADE: 17-SEP-17
Sandy UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 3D Echo
JointVue LLC 510(k) NO: K172513(Third Party - Traditional)
ATTN: Mohamed R. Mahfouz PHONE NO : 877 7256920 101
2099 Thunderhead Rd., Suite 104 SE DECISION MADE: 14-SEP-17
Knoxville TN 37922 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited 510(k) NO: K172519(Special)
ATTN: Samantha Neilson PHONE NO : 44 1482 673790
101 Hessle Road SE DECISION MADE: 15-SEP-17
Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited 510(k) NO: K172521(Special)
ATTN: Samantha Neilson PHONE NO : 44 1482 673790
101 Hessle Road SE DECISION MADE: 20-SEP-17
Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mazor X
Mazor Robotics Ltd. 510(k) NO: K172522(Special)
ATTN: Shiran Conforti PHONE NO : 972 4 6187100
5 Shacham St. North Industrial ParSE DECISION MADE: 15-SEP-17
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IV Fat Emulsion Administration Sets
Baxter Healthcare Corporation 510(k) NO: K172544(Special)
ATTN: Jill M. Laack PHONE NO : 224 2702686
32650 N. Wilson Road SE DECISION MADE: 22-SEP-17
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERI Contour
Sofregen Medical, Inc. 510(k) NO: K172545(Special)
ATTN: Anh Hoang PHONE NO : 781 8742352
200 Boston Avenue, Suite 1100 SE DECISION MADE: 22-SEP-17
Medford MA 02155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Hologic, Inc. 510(k) NO: K172566(Special)
ATTN: Catherine Sanford PHONE NO : 508 2638604
250 Campus Drive SE DECISION MADE: 20-SEP-17
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASCORE Focused Force PTA Balloon
C.R. Bard 510(k) NO: K172571(Special)
ATTN: Jonathan Holmes PHONE NO : 480 3506161
1625 W 3rd St SE DECISION MADE: 22-SEP-17
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CareView 1800Cw X-ray Flat Panel Detectors
CareRay Digital Medical System Co.510(k) NO: K172581(Special)
ATTN: Xu Wei PHONE NO : 86 5128 6860288109
B3-501, Biobay, 218 Xinghu Street,SE DECISION MADE: 26-SEP-17
SuZhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
Medacta International SA 510(k) NO: K172587(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 18-SEP-17
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA Excel+ Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation 510(k) NO: K172595(Special)
ATTN: Alexandra Wells PHONE NO : 609 7507872
311 Enterprise Drive SE DECISION MADE: 28-SEP-17
PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FiberTak DX
Arthex, Inc 510(k) NO: K172612(Special)
ATTN: Ivette Galmez PHONE NO : 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 28-SEP-17
Naples FL 34108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECICE System
NuVasive Specialized Orthopedics, 510(k) NO: K172628(Traditional)
ATTN: Cora Sim PHONE NO : 949 5446478
101 Enterprise, Suite 100 SE DECISION MADE: 25-SEP-17
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arisure Dry Spike
Yukon Medical 510(k) NO: K172631(Third Party - Traditional)
ATTN: Todd Korogi PHONE NO : 919 5958250
4021 Stirrup Creek Dr. Suite #200 SE DECISION MADE: 29-SEP-17
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
M/s. Meril Endo Surgery Private Li510(k) NO: K172659(Special)
ATTN: Umesh Sharma PHONE NO : 91 0260 3052100
Third Floor, E1-E3, Meril Park SurSE DECISION MADE: 28-SEP-17
Chala, Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 246
TOTAL WITH SUMMARIES 236
TOTAL WITH STATEMENTS 10
