510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2018
DEVICE: Omega VL
OV WORLD CO., LTD 510(k) NO: K162366(Traditional)
ATTN: GEUNG-GYU GANG PHONE NO : 82 2 8380561
(GASAN-DONG, FORMATEC BD)A-202,213SE DECISION MADE: 02-MAR-18
SEOUL KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrist Type Blood Pressure Monitor
Xuzhou Yongkang Electronic Science510(k) NO: K162616(Traditional)
ATTN: YanLi Li PHONE NO : 8686 51687 892766631
4F Building C8,40 Jingshan Road EcSE DECISION MADE: 09-MAR-18
Xuzhou CN 102628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
RAPID Biomedical GmbH 510(k) NO: K163661(Traditional)
ATTN: Christian Zimmermann PHONE NO : 49 9365 88260
Kettelerstr. 3-11 SE DECISION MADE: 21-MAR-18
Rimpar DE 97222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers
Astell Scientific Limited 510(k) NO: K170304(Traditional)
ATTN: Gary Doughty PHONE NO : 44 020 83092003
19-21 Powerscroft Rd SE DECISION MADE: 02-MAR-18
Sidcup GB DA14 5DT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Longeviti PMMA Static Cranial Implant
Longeviti Neuro Solutions, LLC 510(k) NO: K170410(Traditional)
ATTN: Kevin Lee PHONE NO : 410 5271803
303 International Circle Suite T12SE DECISION MADE: 23-MAR-18
Hunt Valley MD 21030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D
Jiangsu Yuyue Medical Equipment& S510(k) NO: K170605(Traditional)
ATTN: Rong Zhong PHONE NO : 511 869 00827
Yunyang Industrial Park Danyang, JSE DECISION MADE: 27-MAR-18
Danyang CN 212300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UF(II) Implant System
DIO Corporation 510(k) NO: K170608(Traditional)
ATTN: Jiae Park PHONE NO : 82 517 457789
66, Centum seo-ro SE DECISION MADE: 30-MAR-18
Busan KR 48058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acculoc Total Knee System
RootLoc Co., Ltd. 510(k) NO: K170753(Traditional)
ATTN: Jungsun Ha PHONE NO : 82 2 69414341
#1210, 68, Digital-ro 9-gil SE DECISION MADE: 23-MAR-18
Geumcheon-gu KR 08512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReConnex Pre-Sutured Tendon
AlloSource 510(k) NO: K170957(Traditional)
ATTN: Pamela Vetter PHONE NO : 720 8730213
6278 S Troy Circle SE DECISION MADE: 20-MAR-18
Centennial CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO Check Pro, CO Screen
MD Diagnostics Limited 510(k) NO: K171129(Traditional)
ATTN: Glen Hillsley PHONE NO : 44 0 1622682686
15 Hollingworth Court, Turkey MillSE DECISION MADE: 02-MAR-18
Maidstone GB ME14 5pp 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AW-100
Micron Corporation 510(k) NO: K171150(Traditional)
ATTN: Takashi Terui PHONE NO : 81 3 37550396
2-17-7 Ikegami SE DECISION MADE: 08-MAR-18
Ota-ku, Tokyo JP 146-0082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Shenzhen Brav Electronic Technolog510(k) NO: K171214(Traditional)
ATTN: Aaron Wan PHONE NO : 86 075 529781489
4/F, Block 11, Tongfuyu IndustrialSE DECISION MADE: 02-MAR-18
Shenzhen CN 518102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Hunan Accurate Bio-Medical Technol510(k) NO: K171241(Traditional)
ATTN: Zhou Le PHONE NO : 86 731 89745029
M8-613, No.8, Lutian Road, ChangshSE DECISION MADE: 27-MAR-18
Changsha CN 410208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws
Meril Healthcare Pvt. Ltd. 510(k) NO: K171320(Traditional)
ATTN: Umesh Sharma PHONE NO : 91 260 3052100
First Floor, H1-H3, Meril Park, SuSE DECISION MADE: 08-MAR-18
Muktanand Marg, Chala, Vapi IN 39510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Incontinence Treatment Device, Model LT2061
Shenzhen Dongdixin Technology Co.,510(k) NO: K171430(Traditional)
ATTN: Truman Shen PHONE NO : 0086 755 27652471
No. 3 Building, XiLiBaimang XushenSE DECISION MADE: 15-MAR-18
Shenzhen CN 518108 510(k) STATEMENT
DEVICE: TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
Dr. Harold Katz, LLC (dba TheraBre510(k) NO: K171542(Traditional)
ATTN: Harold Katz PHONE NO : 323 7628518
5802 Willoughby Avenue SE DECISION MADE: 16-MAR-18
Los Angeles CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IXOS Radius Plate System
Stuckenbrock Medizintechnik GmbH 510(k) NO: K171624(Traditional)
ATTN: Fabian Stuckenbrock PHONE NO : 49 07461 165880
Lessingstraße 50 SE DECISION MADE: 29-MAR-18
Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas m 511 integrated hematology analyzer
Roche Diagnostics Hematology, Inc.510(k) NO: K171655(Traditional)
ATTN: Dan Bracco PHONE NO : 508 3292455
69 Milk Street, Suite 120 SE DECISION MADE: 02-MAR-18
Westborough MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUMA System
Panther Orthopedics, Inc. 510(k) NO: K171703(Traditional)
ATTN: Kathryn Stecco PHONE NO : 408 9303332
5279 Apennines Circle SE DECISION MADE: 01-MAR-18
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HammerTube System
Paragon 28 510(k) NO: K171715(Traditional)
ATTN: Frank S. Bono PHONE NO : 888 7281888
4B Inverness Ct. E., STE 280 SE DECISION MADE: 05-MAR-18
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Citric Complete Dry Citric Acid (45X)
Dimesol USA, LLC 510(k) NO: K171750(Traditional)
ATTN: Marlene Van Dyke PHONE NO : 717 9388391
509 Fishing Creek Road SE DECISION MADE: 06-MAR-18
Lewisberry PA 17339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fixed Core Wire Guides
Cook Incorporated 510(k) NO: K171764(Traditional)
ATTN: Jennifer Allman PHONE NO : 812 3353575 104280
750 Daniels Way SE DECISION MADE: 09-MAR-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR Wireless Gating System, Model WGS-100
Ivy Biomedical Systems, Inc 510(k) NO: K171778(Traditional)
ATTN: Nicole Bush PHONE NO : 203 4814183
11 Business Park Drive SE DECISION MADE: 14-MAR-18
Branford CT 06405 510(k) STATEMENT
DEVICE: ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
Bayer HealthCare LLC 510(k) NO: K171802(Traditional)
ATTN: Cindy R. Abraham PHONE NO : 862 4047022
100 Bayer Boulevard SE DECISION MADE: 07-MAR-18
Whippany NJ 07981-0915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TDM Plate and Screw System
TDM Co. Ltd. 510(k) NO: K171808(Traditional)
ATTN: Babu Periasamy PHONE NO :
#F105-1.101-104, Sangsan-dong, 333SE DECISION MADE: 15-MAR-18
Gwangju KR 61008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
Cook Incorporated 510(k) NO: K171810(Traditional)
ATTN: Yan Li PHONE NO : 812 3353575 104987
750 Daniels Way P.O. Box 489 SE DECISION MADE: 07-MAR-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodesign Diaphragmatic Hernia Graft
Cook Biotech Incorporated 510(k) NO: K171817(Traditional)
ATTN: Perry W. Guinn PHONE NO : 765 4973355
1425 Innovation Place SE DECISION MADE: 13-MAR-18
West Lafayette IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transjugular Liver Access Sets
Cook Incorporated 510(k) NO: K171820(Traditional)
ATTN: David Lehr PHONE NO : 812 3392235 2309
750 Daniels Way SE DECISION MADE: 09-MAR-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Shoulder System
Arthrex Inc. 510(k) NO: K171841(Traditional)
ATTN: David L. Rogers PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 29-MAR-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFTXIL
BISTOOL 510(k) NO: K171851(Traditional)
ATTN: Eunhyun Bae PHONE NO : 82 234 467688
9, Gwangnaru-ro 6-gil Seongdong-guSE DECISION MADE: 16-MAR-18
Seoul KR 04796 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSure® Enteral Feeding Syringe with ENFit Tip
Amsino International, Inc. 510(k) NO: K171857(Traditional)
ATTN: Cathy Hong PHONE NO : 909 6265888
708 Corporate Center Drive SE DECISION MADE: 30-MAR-18
Pomona CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anjon Bremer Halo System
Anjon Holdings, LLC 510(k) NO: K171863(Traditional)
ATTN: Tommy Mitchell PHONE NO : 904 7309373
4801 Dawin Rd SE DECISION MADE: 19-MAR-18
Jacksonville FL 32207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dr’s Finder NEO
Good Doctors Co.,Ltd. 510(k) NO: K171867(Traditional)
ATTN: Sungro Joo PHONE NO : 82 32 4246325
#208, B-Dong, 283 Bupyeong-Daero, SE DECISION MADE: 30-MAR-18
Incheon KR 21315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Double Flexible Tip Wire Guides
Cook Incorporated 510(k) NO: K171912(Traditional)
ATTN: Jennifer Allman PHONE NO : 812 3353575 104280
750 Daniels Way SE DECISION MADE: 19-MAR-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nathanson Transcystic Bile Duct Stone Exploration Pack
Cook Incorporated 510(k) NO: K171915(Traditional)
ATTN: Colin Jacob PHONE NO : 812 3353575 104965
450 Daniels Way, P.O. Box 489 SE DECISION MADE: 01-MAR-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property Gm510(k) NO: K171937(Traditional)
ATTN: Gerhard Frick PHONE NO : 4 171 7277059
Espenstrasse 139 SE DECISION MADE: 16-MAR-18
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALVUE Balloon Dilation System
Globus Medical, Inc. 510(k) NO: K171939(Traditional)
ATTN: Lori Burns PHONE NO : 610 9301800 2950
2560 General Armistead Ave. ValleySE DECISION MADE: 07-MAR-18
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dimesol Tubing Sets for Hemodialysis
Dimesol, Inc. 510(k) NO: K171952(Traditional)
ATTN: Stephen P. Callaghan PHONE NO : 717 9388391
509 Fishing Creek Road SE DECISION MADE: 30-MAR-18
Lewisberry PA 17339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mpact® 3D Metal™ Implants and Augments 3D Metal™
Medacta International SA 510(k) NO: K171966(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 27-MAR-18
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket
Wilson-Cook Medical, Inc. 510(k) NO: K171969(Traditional)
ATTN: Ashley Howard PHONE NO : 1 336 7440157 6174
4900 Bethania Station Road SE DECISION MADE: 28-MAR-18
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Captura® Disposable Hot Biopsy Forceps
Wilson-Cook Medical, Inc. 510(k) NO: K171973(Traditional)
ATTN: Ashley Howard PHONE NO : 336 7440157 6174
4900 Bethania Station Road SE DECISION MADE: 21-MAR-18
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DROPLET PEN NEEDLE
HTL-STREFA S.A. 510(k) NO: K171982(Traditional)
ATTN: Aleksandra Prazmowska-WilanPHONE NO : 48 42 2700010
Adamowek 7 SE DECISION MADE: 21-MAR-18
Ozorkow PL 95-035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Performer Guiding Sheath
Cook Incorporated 510(k) NO: K171988(Traditional)
ATTN: Reuben G. Lidster PHONE NO : 812 3353575 104866
750 Daniels Way P.O. Box 489 SE DECISION MADE: 30-MAR-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter
Wilson-Cook Medical Inc. 510(k) NO: K171989(Traditional)
ATTN: Ashley Howard PHONE NO : 336 7440157 6174
4900 Bethania Station Road SE DECISION MADE: 20-MAR-18
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mandril Wire Guide
Cook Incorporated 510(k) NO: K171997(Traditional)
ATTN: Jennifer Allman PHONE NO : 1 812 3353575 104280
750 Daniels Way SE DECISION MADE: 30-MAR-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: star RF Electrode, VIV A RF Electrode
STARmed Co., Ltd. 510(k) NO: K172012(Traditional)
ATTN: Jun-Young Jung PHONE NO : 82 70 46738657
B-dong, 4F, 158, Haneulmaeul-ro, ISE DECISION MADE: 14-MAR-18
Gyeonggi-do KR 10355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Black Silicone Filiform Double Pigtail Stent Set
Cook Incorporated 510(k) NO: K172017(Traditional)
ATTN: Karthik Pillai PHONE NO : 812 3353575 104929
750 Daniels Way P.O. Box 489 SE DECISION MADE: 26-MAR-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EKOS ultrasound EVD Device, EVD Control Unit
BTG International, Inc. 510(k) NO: K172035(Traditional)
ATTN: Brit Baird PHONE NO : 425 4153114
11911 North Creek Pkwy S SE DECISION MADE: 24-MAR-18
Bothell WA 98011 510(k) STATEMENT
DEVICE: Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
Cook Ireland Ltd. 510(k) NO: K172057(Traditional)
ATTN: Orla Gunning PHONE NO : 011 353 61334440 2895
O' Halloran Road, National TechnolSE DECISION MADE: 09-MAR-18
Limerick IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
MedScience Science Research Group,510(k) NO: K172062(Traditional)
ATTN: Marvin Smollar PHONE NO : 561 4990411
16469 Bridlewood Circle SE DECISION MADE: 05-MAR-18
Delray Beach FL 33445 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)
Terumo Cardiovascular Systems Corp510(k) NO: K172071(Traditional)
ATTN: Garry A. Courtney PHONE NO : 800 2623304 7486
125 Blue Ball Road SE DECISION MADE: 29-MAR-18
Elkton MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImmuLisa Enhanced RNA POL III Antibody ELISA
IMMCO Diagnostics, Inc. 510(k) NO: K172078(Traditional)
ATTN: Kevin Lawson PHONE NO : 716 4915245
60 Pineview Dr. SE DECISION MADE: 30-MAR-18
Buffalo NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flowtron DVT5 Small Calf Garment
Getinge (Suzhou) Co., Ltd. 510(k) NO: K172103(Traditional)
ATTN: Daisy Qin PHONE NO : 86 512 69561698
No. 158 Fangzhou Road SE DECISION MADE: 02-MAR-18
Suzhou CN 2015024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navigated Instrument System
Orthofix Inc. 510(k) NO: K172115(Special)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 08-MAR-18
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uCT Computed Tomography X-ray System
Shanghai United Imaging Healthcare510(k) NO: K172135(Traditional)
ATTN: Shumei Wang PHONE NO : 86 2167 0768886776
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 02-MAR-18
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anchorage Bone Plating System
Stryker GmbH 510(k) NO: K172148(Traditional)
ATTN: Jackie Perri PHONE NO : 732 7705616
325 Corporate Drive SE DECISION MADE: 19-MAR-18
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WillCeph
HDX WILL CORP. 510(k) NO: K172168(Traditional)
ATTN: Myoung-Joon Lee PHONE NO : 82 43 7107318
#105, 106, 201, 202, 203, 204, 38,SE DECISION MADE: 21-MAR-18
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoreHip® System
Aesculap Implants Systems, LLC 510(k) NO: K172235(Traditional)
ATTN: Paul Amudala PHONE NO : 610 9849147
3773 Corporate Parkway SE DECISION MADE: 28-MAR-18
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS URF-V2/V2R
Olympus Medical Systems Corp. 510(k) NO: K172246(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 30-MAR-18
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SoftVue
Delphinus Medical Technologies 510(k) NO: K172256(Traditional)
ATTN: Francis X. Dobscha PHONE NO : 248 5229508
45525 Grand River Avenue SE DECISION MADE: 02-MAR-18
Novi MI 48374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTW Takeru PTCA Balloon Dilatation Catheter
Kaneka Corporation 510(k) NO: K172264(Special)
ATTN: Toshihiko Motomine PHONE NO : 81 3 55748023
1-12-32, Akasaka, Minato-ku SE DECISION MADE: 19-MAR-18
Tokyo JP 107-6028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dynarex Three-Way Stopcock
Dynarex Corporation 510(k) NO: K172266(Traditional)
ATTN: Pablo Martinez PHONE NO : 845 3986616
10 Glenshaw Street SE DECISION MADE: 14-MAR-18
Orangeburg NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRENE Thoracolumbar Fixation System
Tianjin Zhengtian Medical Instrume510(k) NO: K172267(Traditional)
ATTN: Ou Changli PHONE NO : 86 10 822929
No. 318, Jingyi Road, Airport EconSE DECISION MADE: 06-MAR-18
Tianjin CN 300308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
Globus Medical, Inc. 510(k) NO: K172269(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 27-MAR-18
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS URF-P6/P6R
Olympus Medical Systems Corp. 510(k) NO: K172298(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 29-MAR-18
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eego amplifiers
eemagine Medical Imaging Solutions510(k) NO: K172312(Traditional)
ATTN: Frank Zanow PHONE NO : 49 30 29048404
Gubenerstr. 47, Fabrik D-10243 SE DECISION MADE: 30-MAR-18
Berlin DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica IM Total hCG (ThCG)
Siemens Healthcare Diagnostics Inc510(k) NO: K172322(Traditional)
ATTN: Anoop Joy PHONE NO : 914 5242273
511 Benedict Avenue SE DECISION MADE: 29-MAR-18
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Type I, Type II, Type III, Type IV
Lepu Medical Technology (Beijing) 510(k) NO: K172331(Traditional)
ATTN: Xiangdan Jin PHONE NO : 86 10 80123510
No. 37 Chaoqian Road SE DECISION MADE: 02-MAR-18
Beijing CN 102200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bleep DreamPort
snapCPAP 510(k) NO: K172335(Traditional)
ATTN: Stuart Heatherington PHONE NO : 919 6197170
143 Harrison Pond Dr. SE DECISION MADE: 30-MAR-18
Pittsboro NC 37312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OssBuilder System
Osstem Implant Co., Ltd.. 510(k) NO: K172354(Traditional)
ATTN: Jungmin Yoo PHONE NO : 82 51 8502575
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 26-MAR-18
Busan KR 612-070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrist Pulse Oximeter
Beijing Choice Electronic Technolo510(k) NO: K172366(Traditional)
ATTN: Lei Chen PHONE NO : 86 10 88798300 6020
No.9 Shuangyuan road, Badachu Hi-tSE DECISION MADE: 16-MAR-18
Beijing CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex UNIVERS REVERS COATED BASEPLATE
Arthrex, Inc. 510(k) NO: K172371(Traditional)
ATTN: Courtney Smith PHONE NO : 1 239 6435553 71720
1370 Creekside Boulevard SE DECISION MADE: 22-MAR-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digitimer DS7AP Constant Current Stimulator
Digitimer Ltd. 510(k) NO: K172381(Traditional)
ATTN: John Smale PHONE NO : 44 01707 328347
37 Hydeway SE DECISION MADE: 06-MAR-18
Welwyn Garden City GB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardiovascular Analzyer
PhysioWave, Inc. 510(k) NO: K172431(Traditional)
ATTN: Laurent Giovangrandi PHONE NO : 408 6380008
1700 Wyatt Drive Suite 2 SE DECISION MADE: 14-MAR-18
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSA BRAIN (v3.0.0.5)
MEDTECH S.A. 510(k) NO: K172444(Traditional)
ATTN: Elise Lagacherie PHONE NO : 33 46 7107740
ZAC Eureka - 900 Rue Du Mas De VerSE DECISION MADE: 28-MAR-18
Montpellier FR 34000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
Aesku.Diagnostics GmbH & Co. KG 510(k) NO: K172461(Traditional)
ATTN: Sandra Reuter PHONE NO : 49 6734 96220
Mikro-Forum-Ring 2 SE DECISION MADE: 23-MAR-18
Wendelsheim DE 55234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Footmotion HammerToe
Newclip Technics 510(k) NO: K172485(Traditional)
ATTN: Gaelle Lussori PHONE NO : 33 2 28213712
PA de la Lande Saint Martin - 45 rSE DECISION MADE: 02-MAR-18
Haute-Goulaine FR 44 115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERCATH 5 (26G)
TOGO Medikit Co., Ltd. 510(k) NO: K172496(Traditional)
ATTN: Daisuke Nagamizu PHONE NO : 11 81 982538000
17148-6 Aza Kamekawa Oaza Hichiya SE DECISION MADE: 23-MAR-18
Hyuga City JP 883-0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Technoweb Surgical Mask
YTS GLOBAL INC. 510(k) NO: K172500(Traditional)
ATTN: Eddie Nguyen PHONE NO : 703 3408178
7406 ALBAN STATION CT STE A 108 SE DECISION MADE: 01-MAR-18
SPRINGFIELD VA 22150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurgiQuest AIRSEAL iFS System
ConMed Corporation 510(k) NO: K172516(Traditional)
ATTN: Lisa Anderson PHONE NO : 203 7992400 202
488 Wheelers Farms Road SE DECISION MADE: 16-MAR-18
Milford CT 06461 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectra Optia Apheresis System
Terumo BCT, Inc. 510(k) NO: K172590(Traditional)
ATTN: Nicholas Wong PHONE NO : 303 2392384
10811 W. Collins Avenue SE DECISION MADE: 02-MAR-18
Lakewood CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XCelliStem Wound Powder
StemSys 510(k) NO: K172593(Traditional)
ATTN: Clay Fette PHONE NO : 561 3249507
10871 NW 52nd St, Ste 4 SE DECISION MADE: 16-MAR-18
Sunrise FL 33351 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Next Generation iBOT
DEKA Research & Development Corp 510(k) NO: K172601(Traditional)
ATTN: Roger Leroux PHONE NO : 603 6695139
340 Commercial St. SE DECISION MADE: 02-MAR-18
Manchester NH 03101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths
Varian Medical Systems, Inc 510(k) NO: K172611(Special)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 21-MAR-18
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
Runbio BioTech Co.,Ltd 510(k) NO: K172627(Traditional)
ATTN: Chandler Chen PHONE NO : 86 186 88026317
Rongsheng Technology Garden, ShantSE DECISION MADE: 28-MAR-18
Shantou CN 515063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
DeVilbiss Healthcare, LLC 510(k) NO: K172648(Traditional)
ATTN: Betty Miller PHONE NO : 814 4437602
100 DeVilbiss Drive SE DECISION MADE: 23-MAR-18
Somerset PA 15501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cytology Brush
Micro-Tech (Nanjing) CO., Ltd. 510(k) NO: K172663(Traditional)
ATTN: Becky Li PHONE NO : 86 25 58646378
NO. 10 Gaoke Third Road SE DECISION MADE: 05-MAR-18
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dario LC Blood Glucose Monitoring System
LabStyle Innovation, Ltd. 510(k) NO: K172723(Traditional)
ATTN: Erez Raphael PHONE NO : 972 52 5522685
9 Halamish Street, North IndustriaSE DECISION MADE: 23-MAR-18
Caesarea IL 3890000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rotatable Snares, Non-Rotatable Snares
Zhejiang Chuangxiang Medical Techn510(k) NO: K172758(Traditional)
ATTN: Lucius Long PHONE NO : 8657 189167 0888187
301B, No.22, XinYan Road SE DECISION MADE: 07-MAR-18
Hanzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REST EAZY Appliance
Insert Molding Solutions, Inc. 510(k) NO: K172760(Traditional)
ATTN: Paul Hendrixson PHONE NO : 678 9655334
4325 Settingdown Circle, Suite 103SE DECISION MADE: 26-MAR-18
Cumming GA 30028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Hemoclip
Zhejiang Chuangxiang Medical Techn510(k) NO: K172762(Traditional)
ATTN: Lucius Long PHONE NO : 865718 916708 88187
301B, No.22, XinYan Road SE DECISION MADE: 20-MAR-18
Hanzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Shenzhen Jumper Medical Equipment 510(k) NO: K172795(Traditional)
ATTN: Rambo Yang PHONE NO : 86 755 26696279
D Building, No. 71, Xintian Road, SE DECISION MADE: 14-MAR-18
Shenzhen CN 518102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Positional Sleep Assessment System (PoSAS) software
Advanced Brain Monitoring 510(k) NO: K172799(Traditional)
ATTN: Daniela Soll PHONE NO : 760 7200099 6006
2237 Faraday Ave, Suite 100 SE DECISION MADE: 09-MAR-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORT-X IV
GENORAY Co., Ltd. 510(k) NO: K172810(Traditional)
ATTN: Ji-Yeon Choi PHONE NO : 82 31 6273953
512, 560, Dunchon-daero, Jungwon-gSE DECISION MADE: 07-MAR-18
Seongnam KR 13230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LMT-3000
Lameditech Co., Ltd. 510(k) NO: K172818(Traditional)
ATTN: Jong Seuk Choi PHONE NO : 82 70 42081082
#1002, ACE High End Tower 6th SE DECISION MADE: 07-MAR-18
234, Beotkkot-ro, Geumcheon-gu KR510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microscope Navigation Software
Brainlab AG 510(k) NO: K172820(Traditional)
ATTN: Alexander Schwiersch PHONE NO : 49 89 9915680
Olof-Palme-Str. 9 SE DECISION MADE: 01-MAR-18
Munich DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TwitchView System
Blink Device Corporation 510(k) NO: K172843(Traditional)
ATTN: Justin Hulvershorn PHONE NO : 206 2953372
1530 Westlake Ave N Suite 600 SE DECISION MADE: 29-MAR-18
Seattle WA 98109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Femoral Neck System
DePuy Synthes 510(k) NO: K172872(Traditional)
ATTN: Ana Sala Roca PHONE NO : 41 32 7204573
Luzernstrasse 21 SE DECISION MADE: 05-MAR-18
Zuchwil CH 4528 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Dongguan HCS Electronics Co., Ltd 510(k) NO: K172891(Traditional)
ATTN: Angel You PHONE NO : 86 769 82553442
Floor 4, Building 1, No.1 Longtan SE DECISION MADE: 16-MAR-18
Dongguan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuro Assessment System NAS-1000
HeadSense Medical Inc. 510(k) NO: K172892(Traditional)
ATTN: Richard A. Lotti PHONE NO : 234 6783888
520 S. Main St. Suite 2457 SE DECISION MADE: 08-MAR-18
Akron OH 44311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603
Fujifilm Corporation 510(k) NO: K172916(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 01-MAR-18
Ashigarakami-Gun Kanagawa JP 258-510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable X-ray System
Rolence Enterprise Inc. 510(k) NO: K172928(Traditional)
ATTN: Sterling Cheng PHONE NO : 886 3 4631999
18-3 Lane 231 Pu Chung Rd., ChunglSE DECISION MADE: 16-MAR-18
Taoyuan TW 32083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrist Type Automatic Blood Pressure Monitor
Shenzhen Jiacom Technology Co., Lt510(k) NO: K172972(Traditional)
ATTN: Luo Tianfeng PHONE NO : 86 755 29015600
No. A6 Building, Silicon Valley PoSE DECISION MADE: 02-MAR-18
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nipro Syringe
Nipro Medical Corporation 510(k) NO: K173029(Traditional)
ATTN: Jessica Oswald-McLeod PHONE NO : 786 5676343
3150 NW 107th Ave. SE DECISION MADE: 30-MAR-18
Miami FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Knee Joint Replacement Prostheses MR Labeling
Zimmer, Inc. 510(k) NO: K173057(Traditional)
ATTN: Jason Heckaman PHONE NO : 574 3718313
P.O. Box 708 SE DECISION MADE: 29-MAR-18
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
DxNow, Inc. 510(k) NO: K173075(Abbreviated)
ATTN: William T. Sharp PHONE NO : 240 4549893
401 Professional Drive, Suite 130 SE DECISION MADE: 08-MAR-18
Gaithersburg MD 20879-3429 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder-free Clear Vinyl Patient Examination Gloves
Yongsheng Medical Products Co., Lt510(k) NO: K173078(Traditional)
ATTN: Jason Wei PHONE NO : 86 189 54428069
No.277, Yangtianshan Road SE DECISION MADE: 09-MAR-18
Qingzhou CN 255000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arco™-SA Lumbar Cage System
NeuroStructures, Inc. 510(k) NO: K173082(Traditional)
ATTN: Kathleen Wong PHONE NO : 949 3704497
16 Technology Drive Suite 165 SE DECISION MADE: 29-MAR-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
Cook Incorporated 510(k) NO: K173105(Traditional)
ATTN: Samuel Engelman PHONE NO : 812 3392235 104340
750 Daniels Way SE DECISION MADE: 22-MAR-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: primeMidline Catheters
PFM Medical, Inc. 510(k) NO: K173114(Traditional)
ATTN: Jessica Jho PHONE NO : 760 7588749
1916 Palomar Oaks Way Suite 150 SE DECISION MADE: 07-MAR-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CCM Abutment System
InnoBioSurg Co., Ltd. 510(k) NO: K173120(Traditional)
ATTN: Bo-reum Yoo PHONE NO : 82 42 9332879
44-19, Techno 10-ro, Yuseong-gu SE DECISION MADE: 16-MAR-18
Daejeon KR 34027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alamo® C
Alliance Partners, LLC 510(k) NO: K173128(Traditional)
ATTN: Kristiina Gilkey PHONE NO : 1 210 3142525
14206 Northbrook Dr. SE DECISION MADE: 22-MAR-18
San Antonio TX 78232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTIO MMG Pedicle Access Needles
Medos International SARL 510(k) NO: K173134(Traditional)
ATTN: Sheree Geller PHONE NO : 508 8283291
Chemin-Blanc 38 SE DECISION MADE: 22-MAR-18
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mega Plus Spine System
BK MEDITECH Co., Ltd. 510(k) NO: K173180(Traditional)
ATTN: Byoungjun Park PHONE NO : 82 313 529135
58, Eunhaengnamu-ro, Yanggam-myeonSE DECISION MADE: 15-MAR-18
Hwaseong-si KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExSpiron 1Xi
Respiratory Motion Inc. 510(k) NO: K173181(Traditional)
ATTN: Susan Hamann PHONE NO : 781 7951595
411 Waverly Oaks Road, Building 1,SE DECISION MADE: 16-MAR-18
Waltham MA 02452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Athena GTX Device Management Suite (ADMS) Software
Athena GTX 510(k) NO: K173203(Traditional)
ATTN: Sean Mahoney PHONE NO : 515 2883360 103
5900 NW 86th Street, Suite 300 SE DECISION MADE: 14-MAR-18
Johnston IA 50131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NES Reprocessed RF Stylet (RFS)
Northeast Scientific, Inc. (NES) 510(k) NO: K173214(Traditional)
ATTN: Matthew Farley PHONE NO : 203 7562111
2142 Thomaston Avenue SE DECISION MADE: 27-MAR-18
Waterbury CT 06704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ologen Collagen Matrix
Aeon Astron Europe B.V. 510(k) NO: K173223(Special)
ATTN: Horng Ji Lai PHONE NO : 31 71 3322280
J.H. Oortweg 19 SE DECISION MADE: 02-MAR-18
Leiden NL 2333 CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Preview Digital Pregnancy Test
Guangzhou Wondfo Biotech Co., Ltd.510(k) NO: K173229(Traditional)
ATTN: Bin Chen PHONE NO : 86 20 32296069
No.8 Lizhishan Road, Science City SE DECISION MADE: 12-MAR-18
Guangzhou CN 510641 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
Syendgen, Inc. 510(k) NO: K173237(Traditional)
ATTN: Shenda Baker PHONE NO : 909 4476858
1420 N. Claremont Blvd. Suite 105DSE DECISION MADE: 19-MAR-18
Claremont CA 91711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED-TAB
PLUM Medical Solutions GmbH 510(k) NO: K173241(Traditional)
ATTN: Arpad Bischof PHONE NO : 49 381 49658280
Lange StraBe 16 SE DECISION MADE: 23-MAR-18
Rostock DE 18055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON™ Spinal System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K173249(Traditional)
ATTN: Ankit K. Shah PHONE NO : 901 3963133
1800 Pyramid Pl SE DECISION MADE: 08-MAR-18
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: System 1 endo Liquid Chemical Sterilant Processing System
Steris Corporation 510(k) NO: K173256(Traditional)
ATTN: Marcia L Benedict PHONE NO : 440 3927063
5976 Heisley Rd SE DECISION MADE: 02-MAR-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
Innovative Health, Llc. 510(k) NO: K173262(Traditional)
ATTN: Amy Stoklas-Oakes PHONE NO : 480 5256006
1435 North Hayden Road Suite 100 SE DECISION MADE: 06-MAR-18
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LigaSure Exact Dissector, Nano-coated
Covidien 510(k) NO: K173281(Traditional)
ATTN: Celso Duran PHONE NO : 303 5306445
5920 Longbow Drive SE DECISION MADE: 02-MAR-18
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartTouch
Adherium (NZ) Ltd 510(k) NO: K173310(Traditional)
ATTN: Chris Mander PHONE NO : 64 9 3072771
Level 2, 204 Quay Street SE DECISION MADE: 26-MAR-18
Auckland NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProBx Software
Harmonus Inc. 510(k) NO: K173312(Traditional)
ATTN: Nicole Mauro PHONE NO : 617 7022271
110 Canal St 3rd Floor SE DECISION MADE: 02-MAR-18
Lowell MA 01852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AnastoClip GC Closure System
LeMaitre Vascular, Inc. 510(k) NO: K173323(Traditional)
ATTN: Xiang Zhang PHONE NO : 781 4251729
63 Second Ave. SE DECISION MADE: 08-MAR-18
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS CONNECT Conical Connection Abutment
MIS Implants Technologies LTD. 510(k) NO: K173326(Traditional)
ATTN: Noa Ofer PHONE NO : 972 4 9016829
P.O. Box 7 Bar Lev Industrial ParkSE DECISION MADE: 16-MAR-18
Bar Lev Industrial Park IL 201560510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LENSAR Laser System - fs 3D (LLS-fs 3D)
Lensar, Inc. 510(k) NO: K173346(Traditional)
ATTN: Keith Peck PHONE NO : 888 5756412
2800 Discovery Drive Suite 100 SE DECISION MADE: 02-MAR-18
Orlando FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ingenia Elition S and Ingenia Elition X R5.4
Philips Medical Systems Nederland 510(k) NO: K173356(Abbreviated)
ATTN: Jan van de Kerkhof PHONE NO : 31 613 300542
Veenpluis 4-6 SE DECISION MADE: 06-MAR-18
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTAS System
Restoration Robotics, Inc. 510(k) NO: K173358(Traditional)
ATTN: Raymond Lee PHONE NO : 408 8836760
128 Baytech Drive SE DECISION MADE: 16-MAR-18
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann Variobase for Crown AS
Institut Straumann AG 510(k) NO: K173379(Traditional)
ATTN: Gordon Dodds PHONE NO : 49 89 309075291
Lochhamer Schlag 6 SE DECISION MADE: 30-MAR-18
Graefelfing DE 82166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech Equinoxe Stemless Shoulder
Exactech Inc 510(k) NO: K173388(Traditional)
ATTN: Thomas McNamara PHONE NO : 352 3771140
2320 NW 66th Court SE DECISION MADE: 09-MAR-18
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mammomat Revelation
Siemens Medical Solutions, Inc. 510(k) NO: K173408(Traditional)
ATTN: Denise Adams PHONE NO : 610 4486139
40 Liberty Boulevard 65-1A SE DECISION MADE: 21-MAR-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SRT-100+
Sensus Healthcare, Inc. 510(k) NO: K173425(Traditional)
ATTN: Nicolas Soro PHONE NO : 561 9225808
851 Broken Sound Parkway NW Suite SE DECISION MADE: 23-MAR-18
Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
KCI USA, INC. 510(k) NO: K173426(Traditional)
ATTN: Margaret Marsh PHONE NO : 210 2556481
6203 Farinon Drive SE DECISION MADE: 09-MAR-18
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY Chemical Indicator for S40 Sterilant
STERIS Corporation 510(k) NO: K173428(Traditional)
ATTN: Marcia L. Benedict PHONE NO : 440 3927063
5976 Heisley Rd SE DECISION MADE: 02-MAR-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H
3M Company 510(k) NO: K173437(Traditional)
ATTN: Hilary B. Hovde PHONE NO : 651 7360364
3M Center, Building 275-5w-06 SE DECISION MADE: 19-MAR-18
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bloom2 Programmable Electrophysiology Stimulator
Fischer Medical 510(k) NO: K173439(Traditional)
ATTN: Wes Rogers PHONE NO : 303 2428078
3990 Youngfield Street SE DECISION MADE: 29-MAR-18
Wheat Ridge CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carriere SLX 3D Clear
Ortho Organizers, Inc. 510(k) NO: K173440(Traditional)
ATTN: Colleen Boswell PHONE NO : 760 4488730
1822 Aston Avenue SE DECISION MADE: 08-MAR-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit
KCI USA, Inc. 510(k) NO: K173447(Traditional)
ATTN: Melanie Avila PHONE NO :
6203 Farinon Drive SE DECISION MADE: 02-MAR-18
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ingenia Elition S and Ingenia Elition X
Philips Medical Systems Nederland 510(k) NO: K173451(Abbreviated)
ATTN: Jan van de Kerkhof PHONE NO : 31 613 300542
Veenpluis 4-6 SE DECISION MADE: 20-MAR-18
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Valeo® C+CSC with Lumen Interbody Fusion Device
Amedica Corp. 510(k) NO: K173453(Traditional)
ATTN: Jason Parberry PHONE NO : 801 8393562
1885 W 2100 S SE DECISION MADE: 05-MAR-18
Salt Lake City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Olympus Small Intestinal Capsule Endoscope System
Olympus Medical Systems Corp. 510(k) NO: K173459(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 13-MAR-18
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Concentrix MX-AC High-Speed Handpiece
DentalEZ, Inc. 510(k) NO: K173465(Traditional)
ATTN: Dan Laskowitz PHONE NO : 717 2911161
1816 Colonial Village Lane SE DECISION MADE: 28-MAR-18
Lancaster PA 17601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amsco Evolution Medium Steam Sterilizer
STERIS Corporation 510(k) NO: K173481(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 09-MAR-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELERITY 20 HP Challenge Pack
STERIS Corporation 510(k) NO: K173488(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5976 Heisley Rd SE DECISION MADE: 01-MAR-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYN-Pump PH304
W.O.M. World of Medicine GmbH 510(k) NO: K173489(Traditional)
ATTN: Soeren Markworth PHONE NO : 0049 30 39981594
Salzufer 8 SE DECISION MADE: 28-MAR-18
Berlin DE 10587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoSteady G Bone Cement
G21 s.r.l. 510(k) NO: K173494(Traditional)
ATTN: Filippo Foroni PHONE NO : 39 05 3530312
Via Sandro Petrini, 8 SE DECISION MADE: 06-MAR-18
San Possidonio IT 841039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
Stryker Orthopaedics 510(k) NO: K173499(Traditional)
ATTN: Kirsten Lehmuller PHONE NO : 201 8315903
325 Corporate Drive SE DECISION MADE: 19-MAR-18
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMF004A
GC America Inc. 510(k) NO: K173500(Traditional)
ATTN: Mark Heiss PHONE NO : 708 5970900
3737 W. 127th Street SE DECISION MADE: 08-MAR-18
Alsip IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADspeed fit
SHIMADZU corporation 510(k) NO: K173517(Traditional)
ATTN: Toshio Kadowaki PHONE NO : 81 75 8231305
1 Nishinokyo-Kuwabaracho Nakagyo-kSE DECISION MADE: 30-MAR-18
Kyoto JP 604-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
Poiesis Medical, LLC 510(k) NO: K173533(Traditional)
ATTN: Greg Wiita PHONE NO : 561 8427560
1095 Jupiter Park Drive Suite 10 SE DECISION MADE: 29-MAR-18
Jupiter FL 33458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phoenix Wound Matrix
Nanofiber Solutions, Inc. 510(k) NO: K173544(Traditional)
ATTN: Ronald L. Bracken PHONE NO : 770 5977656
4389 Weaver Court North SE DECISION MADE: 02-MAR-18
Hilliard OH 43026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Merit Pursue Microcatheter
Merit Medical Systems, Inc. 510(k) NO: K173548(Traditional)
ATTN: Niloufar Samimi PHONE NO : 801 2084583
1600 West Merit Parkway SE DECISION MADE: 30-MAR-18
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Element System with IBT Electrodes
Infinite Biomedical Technologies, 510(k) NO: K173571(Traditional)
ATTN: Rahul Kaliki PHONE NO : 443 4517175
1101 E 33rd Street Suite E305 SE DECISION MADE: 21-MAR-18
Baltimore MD 21218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
Exactech, Inc. 510(k) NO: K173583(Traditional)
ATTN: Shing Jen Tai PHONE NO : 352 3771140
2320 NW 66th Court SE DECISION MADE: 12-MAR-18
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
Spectrum Medical Ltd 510(k) NO: K173591(Traditional)
ATTN: Mark Drain PHONE NO : 44 0 1242650120
Harrier 4, Meteor Business Park, CSE DECISION MADE: 28-MAR-18
Gloucester GB GL2 9QL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iQMR
Medic Vision - Imaging Solutions L510(k) NO: K173605(Traditional)
ATTN: Eyal Aharon PHONE NO : 972 73 7262226
3 Hayozma Street SE DECISION MADE: 08-MAR-18
Tirat Carmel IL 3903203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM Edge Plus
Siemens Medical Solutions USA, Inc510(k) NO: K173607(Traditional)
ATTN: Alaine Medio PHONE NO : 865 2182703
40 Liberty Boulevard SE DECISION MADE: 21-MAR-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo Application Software
Siemens Medical Solutions, USA Inc510(k) NO: K173611(Traditional)
ATTN: Patricia D. Jones PHONE NO : 610 4486474
40 Liberty Boulevard 65-1A SE DECISION MADE: 16-MAR-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Vida with Compressed Sensing GRASP-VIBE
Siemens Medical Solutions USA, Inc510(k) NO: K173617(Traditional)
ATTN: Cordell L. Fields PHONE NO : 610 4486469
65 Valley Stream Parkway Mailcode SE DECISION MADE: 30-MAR-18
Malvern PA 19533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mimics inPrint
Materialise NV 510(k) NO: K173619(Traditional)
ATTN: Oliver Clemens PHONE NO : 32 16 396280
Technologielaan 15 SE DECISION MADE: 21-MAR-18
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)
Origio a/s 510(k) NO: K173624(Traditional)
ATTN: Tove Kjaer PHONE NO : 45 4 6790220
Knardrupvej 2 SE DECISION MADE: 02-MAR-18
Malov DK 2760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Clinical Extensions
Siemens Medical Solutions USA, Inc510(k) NO: K173625(Traditional)
ATTN: Kimberly Mangum PHONE NO : 610 4486477
40 Liberty Blvd. SE DECISION MADE: 08-MAR-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acclarent ENT Navigation System
Acclarent, Inc 510(k) NO: K173628(Special)
ATTN: James Patrick Garvey PHONE NO : 1 949 7898505
1525-B O’Brien Drive SE DECISION MADE: 10-MAR-18
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence
Siemens Medical Solutions USA, Inc510(k) NO: K173630(Traditional)
ATTN: Kimberly Mangum PHONE NO : 610 4486477
40 Liberty Blvd. SE DECISION MADE: 30-MAR-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Coronary Analysis; syngo.CT Vascular Analysis
Siemens Medical Solutions USA, Inc510(k) NO: K173637(Traditional)
ATTN: Kimberly Mangum PHONE NO : 610 448 6477
40 Liberty Blvd. SE DECISION MADE: 30-MAR-18
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LenSx Laser System
Alcon Laboratories, Inc. 510(k) NO: K173660(Traditional)
ATTN: James Arganda PHONE NO : 949 5057038
20511 Lake Forest Dr SE DECISION MADE: 27-MAR-18
Lake Forest CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sapphire II PRO
OrbusNeich Medical Trading Inc. 510(k) NO: K173680(Traditional)
ATTN: John Pazienza PHONE NO : 954 7300711
5363 NW 35th Avenue SE DECISION MADE: 01-MAR-18
Fort Lauderdale FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L300 Go System
Bioness, Inc. 510(k) NO: K173682(Traditional)
ATTN: Mercedes Bayani PHONE NO : 661 3626690
25103 Rye Canyon Loop SE DECISION MADE: 09-MAR-18
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Grass TWin
Natus Medical Incorporated DBA Exc510(k) NO: K173690(Special)
ATTN: Shane Sawall PHONE NO : 608 8298673
2568 Bristol Circle SE DECISION MADE: 09-MAR-18
Oakville CA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERIZONE VP4 Sterilizer
TSO3, Inc. 510(k) NO: K173694(Traditional)
ATTN: Alexandre Jokci PHONE NO : 418 6510003
2505, Rue Dalton SE DECISION MADE: 13-MAR-18
Quebec CA G1P 3S5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
Phadia AB 510(k) NO: K173704(Traditional)
ATTN: Carina Magnusson PHONE NO : 46 18 165000
Rapsgatan 7P SE DECISION MADE: 02-MAR-18
Uppsala SE 75137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K173713(Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 2 21941594
42, Teheran-ro 108-gil SE DECISION MADE: 08-MAR-18
Seoul KR 06176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPOWR Universal Tibial Baseplate
Encore Medical, L.P. 510(k) NO: K173723(Traditional)
ATTN: Teffany Hutto PHONE NO : 512 8346255
9800 Metric Blvd SE DECISION MADE: 05-MAR-18
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor
Ambu A/S 510(k) NO: K173727(Traditional)
ATTN: Maja Brons PHONE NO : 45 72 252000
Baltorpbakken 13 SE DECISION MADE: 28-MAR-18
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
CooperSurgical, Inc 510(k) NO: K173731(Traditional)
ATTN: Tove Kjaer PHONE NO : 454 6790220
95 Corporate Dr. SE DECISION MADE: 02-MAR-18
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RocaJJ Soft Stents
Promepla SAM 510(k) NO: K173734(Traditional)
ATTN: Alexandre Bareille PHONE NO : 377 9798 4244
9 Avenue Albert II SE DECISION MADE: 12-MAR-18
Monaco MC 98000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed DePuy Mitek Ablation Wand
ReNovo, Inc. 510(k) NO: K173740(Traditional)
ATTN: Mark K. Wells PHONE NO : 1 541 4228880
340 SW Columbia St. SE DECISION MADE: 19-MAR-18
Bend OR 97702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed ArthoCare Ablation Wand
ReNovo, Inc. 510(k) NO: K173741(Traditional)
ATTN: Mark K. Wells PHONE NO : 541 4228880
340 SW Columbia St. SE DECISION MADE: 05-MAR-18
Bend OR 97702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SI Screw System
Zavation Medical Products, LLC 510(k) NO: K173752(Traditional)
ATTN: James M. Phillips PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 16-MAR-18
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monarch Endoscopy Platform (Monarch Platform)
Auris Surgical Robotics, Inc. 510(k) NO: K173760(Traditional)
ATTN: Joy Sacmar PHONE NO : 408 3063537
125 Shoreway Road Suite D SE DECISION MADE: 22-MAR-18
San Carlos CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid
DMAX CO., LTD. 510(k) NO: K173769(Traditional)
ATTN: Hyeon Seok Cho PHONE NO :
37-26, Dasa-ro 71-gil, Dasa-eup, DSE DECISION MADE: 08-MAR-18
Daegu KR 42907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BreathID Hp System
Exalenz Bioscience Ltd. 510(k) NO: K173772(Traditional)
ATTN: Raffi Werner PHONE NO : 972 8 9737521
4 Ha'Maayan st. SE DECISION MADE: 08-MAR-18
Modiin IL 7177872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BreathID Hp Lab System
Exalenz Bioscience Ltd. 510(k) NO: K173777(Traditional)
ATTN: Raffi Werner PHONE NO : 972 8 9737521
4 Ha'Maayan st. SE DECISION MADE: 08-MAR-18
Modiin IL 7177872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REXMONO, PDREX
SM ENG CO., LTD 510(k) NO: K173779(Traditional)
ATTN: Soon-Gu Lee PHONE NO : 82 51 3058016
46, Nakdong-daero 1302beon-gil SE DECISION MADE: 12-MAR-18
Sasang-gu KR 46910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Custom Clear Aligner System
Derby Dental Laboratory 510(k) NO: K173785(Traditional)
ATTN: Reed Nunnally PHONE NO : 800 7456718
3332 Gilmore Industrial Blvd SE DECISION MADE: 13-MAR-18
Louisville KY 40213 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Corkscrew FT
Arthrex Inc. 510(k) NO: K173788(Special)
ATTN: David L Rogers PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 01-MAR-18
Napes FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
Elekta Instrument AB 510(k) NO: K173789(Traditional)
ATTN: Alf Laurell PHONE NO : 011 468 58725400
Kungstensgatan 18 SE DECISION MADE: 30-MAR-18
Stockholm SE 10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
Phadia AB 510(k) NO: K173792(Traditional)
ATTN: Carina Magnusson PHONE NO : 46 18 165000
Rapsgatan 7P SE DECISION MADE: 13-MAR-18
Uppsala SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
Medacta International SA 510(k) NO: K173794(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 14-MAR-18
Castel San Pietro CH Ch-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
Sofradim Production 510(k) NO: K173796(Traditional)
ATTN: Benjamin Rochette PHONE NO : 33 4 74089000
116 avenue du Formans SE DECISION MADE: 09-MAR-18
Trevoux FR 01600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
DiaSorin Molecular LLC 510(k) NO: K173798(Traditional)
ATTN: Sharon Young PHONE NO : 562 2406680
11331 Valley View Street SE DECISION MADE: 14-MAR-18
Cypress CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaviCross 0.018"
Terumo Corporation 510(k) NO: K173799(Traditional)
ATTN: Yuko Watanabe PHONE NO : 732 3024900 4120
44-1, 2-Chome, Hatagaya SE DECISION MADE: 29-MAR-18
Shibuya-Ku, JP 151-0072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorPath GRX System
Corindus, Inc. 510(k) NO: K173806(Traditional)
ATTN: Robert Lavado PHONE NO : 508 6533335 211
309 Waverley Oaks Road SE DECISION MADE: 01-MAR-18
Waltham MA 02452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
In2Bones SAS 510(k) NO: K173811(Traditional)
ATTN: Morgane Grenier PHONE NO : 33 4 72292626
28 chemin du Petit Bois SE DECISION MADE: 15-MAR-18
Ecully FR 69130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyst CSR 3 Peg Glenoids
Catalyst OrthoScience, Inc 510(k) NO: K173812(Traditional)
ATTN: Dale Davison PHONE NO : 239 3259976 102
14710 Tamiami Trail North, Suite 1SE DECISION MADE: 09-MAR-18
Naples FL 34110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tissue of Origin Test Kit-FFPE
Cancer Genetics, Inc. 510(k) NO: K173839(Special)
ATTN: Janet Graff PHONE NO : 323 2243900
1640 Marengo Street 6th Floor SE DECISION MADE: 15-MAR-18
Los Angeles CA 90033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert CT/NG
Cepheid 510(k) NO: K173840(Traditional)
ATTN: Yi-Ping Lin PHONE NO : 408 4006838
904 Caribbean Drive SE DECISION MADE: 16-MAR-18
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
Stryker 510(k) NO: K173841(Traditional)
ATTN: Angelica Beckmann PHONE NO : 510 4132900
47900 Bayside Parkway SE DECISION MADE: 18-MAR-18
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DermaScalp Laser Cap
DermaScalp LLC 510(k) NO: K173846(Traditional)
ATTN: John Carullo PHONE NO : 214 6830724
190 E. Stacy Rd Suite 306-291 SE DECISION MADE: 21-MAR-18
Allen TX 75002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
Becton Dickinson and Company 510(k) NO: K173873(Traditional)
ATTN: Ashanti Brown PHONE NO : 410 3164766
7 Loveton Circle MC:694 SE DECISION MADE: 16-MAR-18
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiniMed Mio Advance infusion set
Unomedical A/S 510(k) NO: K173879(Traditional)
ATTN: Heidi Bjerre Lovkvist PHONE NO : 45 2177 5394
Aaholmvej 1-3 SE DECISION MADE: 05-MAR-18
Osted DK DK-4320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPRmeter 2 CPR Feedback Device
Laerdal Medical AS 510(k) NO: K173886(Traditional)
ATTN: Mari Kaada PHONE NO : 47 51 511700
Tanke Svilandsgate 30 SE DECISION MADE: 23-MAR-18
Stavanger NO 2007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas CT/NG for use on cobas 6800/8800 systems
Roche Molecular Systems, Inc. 510(k) NO: K173887(Traditional)
ATTN: Nobuko Nakajima PHONE NO : 925 7308215
4300 Hacienda Drive SE DECISION MADE: 21-MAR-18
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Granada Medium
Hardy Diagnostics 510(k) NO: K173903(Traditional)
ATTN: Rianna Malherbe PHONE NO : 805 3462766 5714
1430 West McCoy Lane SE DECISION MADE: 22-MAR-18
Santa Maria CA 93455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATS Tonometer Prism
CATS Tonometer, LLC 510(k) NO: K173904(Traditional)
ATTN: Sean J. McCafferty PHONE NO : 520 9754550
1517 N. Wilmot, Suite 143 SE DECISION MADE: 09-MAR-18
Tucson AZ 85712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Test of Variables of Attention (T.O.V.A.)
The TOVA Company 510(k) NO: K173915(Traditional)
ATTN: Chris Holder PHONE NO : 360 6612899
2828 SW Corbett Ave Suite 128 SE DECISION MADE: 22-MAR-18
Portland OR 97201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HX Device
Human Extension Ltd. 510(k) NO: K173919(Traditional)
ATTN: Dalit Doron PHONE NO : 972 9 7669569
45 Hamada Street Poleg Industrial SE DECISION MADE: 20-MAR-18
Netanya IL 4250574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-PTFETM Surgical Suture
CP Medical Inc. 510(k) NO: K173922(Traditional)
ATTN: John Hartigan PHONE NO : 678 7102016
1775 Corporate Dr. Suite 150 SE DECISION MADE: 26-MAR-18
Norcross GA 30093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PYTHON Plate Trial Instruments
Treace Medical Concepts, Inc. 510(k) NO: K173930(Special)
ATTN: Rachel Osbeck PHONE NO : 904 3735940 1304
203 Fort Wade Rd. Suite 150 SE DECISION MADE: 19-MAR-18
Ponte Vedra FL 32081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantib Brain
Quantib BV 510(k) NO: K173939(Traditional)
ATTN: Floor van Leeuwen PHONE NO : 31 108 411749
Westblaak 106 SE DECISION MADE: 09-MAR-18
Rotterdam NL 3012 KM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Central Medicare Sdn. Bhd. 510(k) NO: K173942(Traditional)
ATTN: Arivalagan Subramaniam PHONE NO : 6 05 6290000
PT 2609-2620, BT 8, Jalan ChangkatSE DECISION MADE: 05-MAR-18
Teluk Intan MY 36000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Specular Microscope CEM-530
Nidek Co., Ltd. 510(k) NO: K173980(Traditional)
ATTN: Yoneji Mizuno PHONE NO : 81 533 678901
34-14 Maehama, Hiroishi-cho SE DECISION MADE: 14-MAR-18
Gamagori JP 443-0038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips Incisive CT
Philips Healthcare (Suzhou) Co., L510(k) NO: K180015(Traditional)
ATTN: Gordon Shu PHONE NO : 86 512 67336804
No.258, ZhongYuan Road, Suzhou IndSE DECISION MADE: 20-MAR-18
Suzhou CN 215024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Home Use IPL Beauty Device
Shenzhen Mismon Technology Co., Lt510(k) NO: K180016(Traditional)
ATTN: Vicky Yang PHONE NO : 86 755 66816307
2nd Floor, A2 Building, Zhengfeng SE DECISION MADE: 20-MAR-18
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIRION
Gardia Medical Ltd. 510(k) NO: K180023(Traditional)
ATTN: Vardit Segal PHONE NO : 972 4 6277166
HaEshel 2 SE DECISION MADE: 21-MAR-18
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIROLaser Blue
Dentsply Sirona 510(k) NO: K180044(Traditional)
ATTN: Karl J Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street SuiteSE DECISION MADE: 08-MAR-18
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UriSwab-Urine Collection, Transport and Preservation System
Copan Italia S.p.A. 510(k) NO: K180052(Traditional)
ATTN: Elisabetta Zanella PHONE NO : 39 030 2687290
Via F. Perotti 10 SE DECISION MADE: 23-MAR-18
Brescia IT 25125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genesys Spine AIS-C Cervical Anchored Interbody System
Genesys Spine 510(k) NO: K180056(Traditional)
ATTN: Benjamin V. Keller PHONE NO : 512 3817093
1250 Capital of Texas Highway SoutSE DECISION MADE: 28-MAR-18
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VORTEK URETERAL DOUBLE LOOP STENT
Coloplast Corp 510(k) NO: K180057(Traditional)
ATTN: Cori Ragan PHONE NO : 612 5975106
1601 West River Road North SE DECISION MADE: 09-MAR-18
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraCor Twirl Breast Tissue Marker
Bard Peripheral Vascular, Inc. 510(k) NO: K180061(Traditional)
ATTN: Meghan McKelvey PHONE NO : 480 3506067
1625 W. 3rd Street SE DECISION MADE: 09-MAR-18
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCM-G1 Attachment
The Anspach Effort, Inc. 510(k) NO: K180063(Special)
ATTN: Tamara J West PHONE NO : 561 4943712
4500 Riverside Drive SE DECISION MADE: 27-MAR-18
Palm Beach Gardens FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diazyme Lipoprotein (a) Assay
Diazyme Laboratories, Inc. 510(k) NO: K180074(Traditional)
ATTN: Abhijit Datta PHONE NO : 858 4554762
12889 Gregg Court SE DECISION MADE: 22-MAR-18
Poway CA 92130 510(k) STATEMENT
DEVICE: Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
Gyrus ACMI, Inc. 510(k) NO: K180086(Traditional)
ATTN: Mary Anne Patella PHONE NO : 508 8042690
136 Turnpike Rd. SE DECISION MADE: 08-MAR-18
Southborough MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intellitorq
Gauthier Biomedical, Inc. 510(k) NO: K180092(Traditional)
ATTN: Austin Braganza PHONE NO : 262 5460010
2221 Washington St. SE DECISION MADE: 08-MAR-18
Grafton WI 53024 510(k) STATEMENT
DEVICE: Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
Church & Dwight Co., Inc 510(k) NO: K180104(Traditional)
ATTN: Joelle Reinson PHONE NO : 609 8061671
500 Charles Ewing Blvd. SE DECISION MADE: 14-MAR-18
Ewing NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister
Penumbra, Inc. 510(k) NO: K180105(Special)
ATTN: Richard Kimura PHONE NO : 510 9952034
One Penumbra Place SE DECISION MADE: 08-MAR-18
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ThinkQA
DOSIsoft 510(k) NO: K180106(Traditional)
ATTN: Marc Uszynski PHONE NO : 33 1 41242626
45/47, Avenue Carnot SE DECISION MADE: 13-MAR-18
Cachan FR 94230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARband, STARlight, St. Louis Band
Orthomerica Products, Inc 510(k) NO: K180109(Special)
ATTN: David C. Kerr PHONE NO : 407 2906592
6333 North Orange Blossom Trail SE DECISION MADE: 01-MAR-18
Orlando FL 32810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEON Retrieval Bag
Lexington Medical Inc. 510(k) NO: K180114(Traditional)
ATTN: Donna Gasper PHONE NO : 617 2099817
11 Executive Park Drive SE DECISION MADE: 27-MAR-18
Billerica MA 01862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Imbio Segmentation Editing Tool software
Imbio, LLC 510(k) NO: K180129(Traditional)
ATTN: Vipul Goel PHONE NO : 612 5207360
807 Broadway St NE, #350 SE DECISION MADE: 16-MAR-18
Minneapolis MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THD Anopress with THD SensyProbe
THD SpA 510(k) NO: K180135(Traditional)
ATTN: Maurizio Pantaleoni PHONE NO : 39 0522 634311
Via dell'Industria 1 SE DECISION MADE: 08-MAR-18
Correggio IT 42015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATS Thermal Imaging Probe, ATS Patient Interface Unit
Securus Medical Group, Inc. 510(k) NO: K180148(Special)
ATTN: William J. Gorman PHONE NO : 978 3170836
100 Cummings Center, Suite 215F SE DECISION MADE: 21-MAR-18
Beverly MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
Covidien, llc 510(k) NO: K180149(Traditional)
ATTN: Nancy Sauer PHONE NO : 303 5816791
5920 Longbow Drive SE DECISION MADE: 26-MAR-18
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-spine Cortical Bone Screw System
X-spine Systems, Inc. 510(k) NO: K180153(Traditional)
ATTN: Charlene Brumbaugh PHONE NO : 406 3880480 1128
664 Cruiser Lane SE DECISION MADE: 15-MAR-18
Belgrade MT 59714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
Globus Medical Inc. 510(k) NO: K180156(Traditional)
ATTN: Lori Burns PHONE NO : 610 9301800 295
2560 General Armistead Ave. SE DECISION MADE: 07-MAR-18
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klassic® Knee System
Total Joint Orthopedics, Inc. 510(k) NO: K180159(Traditional)
ATTN: Chris Weaber PHONE NO : 801 4866070
1567 E. Stratford Avenue SE DECISION MADE: 09-MAR-18
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Habib EndoHPB
EMcision Ltd. 510(k) NO: K180165(Traditional)
ATTN: Francois Poulin PHONE NO :
DuCane Road SE DECISION MADE: 20-MAR-18
London GB W12 0HS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PillCam Patency System
Given Imaging Ltd. 510(k) NO: K180171(Traditional)
ATTN: Hilla Debby PHONE NO : 972 4 9097774
2 Hacarmet St. New Industrial ParkSE DECISION MADE: 08-MAR-18
Yoqneam IL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG
Paragon Vision Sciences 510(k) NO: K180172(Traditional)
ATTN: Rich Jefferies PHONE NO : 480 5077660
974 E Impala Ave SE DECISION MADE: 16-MAR-18
Mesa AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Emprint Ablation Visualization Application
Covidien, LLC 510(k) NO: K180192(Traditional)
ATTN: Patti L. Arndt PHONE NO : 303 5816668
5920 Longbow Dr. SE DECISION MADE: 21-MAR-18
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
Paragonix Technologies, Inc. 510(k) NO: K180194(Traditional)
ATTN: Leo Basta PHONE NO : 617 8177790
d/o Vaughn & Asociates 639 GraniteSE DECISION MADE: 30-MAR-18
Braintree MA 021184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Frigitronics adapter
Phakos 510(k) NO: K180195(Traditional)
ATTN: Olivier Aumaitre PHONE NO : 88 149887400
62 Rue Kléber SE DECISION MADE: 16-MAR-18
Montreuil FR 93100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: On Call Express Mobile Blood Glucose Monitoring System
ACON Laboratories, Inc. 510(k) NO: K180196(Special)
ATTN: Qiyi Xie PHONE NO : 858 8758011
10125 Mesa Rim Road SE DECISION MADE: 07-MAR-18
San Diego CA 92126 510(k) STATEMENT
DEVICE: NuVasive® VuePoint® II OCT System
NuVasive, Incorporated 510(k) NO: K180198(Traditional)
ATTN: Michelle Cheung PHONE NO : 858 9093360
7475 Lusk Boulevard SE DECISION MADE: 15-MAR-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Freezpoint
Bovie Medical Corp. 510(k) NO: K180211(Traditional)
ATTN: Sam Niedbala PHONE NO : 855 3552796
5115 Ulmerton Road SE DECISION MADE: 21-MAR-18
Clearwater FL 33760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEMENT-TL
Elemenic Co., Ltd. 510(k) NO: K180224(Traditional)
ATTN: Jo Won Ju PHONE NO : 82 32 6135007
3rd, 34 , Gyeongin-ro 3beon-gil SE DECISION MADE: 15-MAR-18
Bucheon-si KR 14731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polaris Spinal Growth System
Zimmer Biomet Spine, Inc. 510(k) NO: K180227(Traditional)
ATTN: Anthony Michael Maahs PHONE NO : 303 4658923
10225 Westmoor Drive SE DECISION MADE: 15-MAR-18
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SICAT Endo
SICAT GmbH & Co. KG 510(k) NO: K180262(Traditional)
ATTN: Manfred Breuer PHONE NO : 49 228 85469782
Brunnenallee 6 SE DECISION MADE: 12-MAR-18
Bonn DE 53177 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPACT TOUCH Ophthalmic Ultrasound System
Quantel Medical 510(k) NO: K180265(Third Party - Traditional)
ATTN: Maureen O'Connell PHONE NO : 978 2071245
11 rue Bois Joli, CS40015 SE DECISION MADE: 02-MAR-18
Cournon D'Auvergne-Cedex FR 63808510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Ventix Link Knotless Anchor with Inserter
Cayenne Medical, Inc 510(k) NO: K180274(Traditional)
ATTN: Shima Hashemian PHONE NO : 480 4582196
16597 N 92nd Street SE DECISION MADE: 21-MAR-18
Scottsdale AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prelude
MedCom GmbH 510(k) NO: K180308(Traditional)
ATTN: Johannes Messow PHONE NO : 49 6151 9514720
Dolivostrasse 11 SE DECISION MADE: 27-MAR-18
Darmstadt DE 64293 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISKOM
Biopsybell s.r.l. 510(k) NO: K180315(Traditional)
ATTN: Tiziana Bellini PHONE NO : 39 535 27850
Via A. Manuzio n.24 SE DECISION MADE: 26-MAR-18
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
Bausch and Lomb Incorporated 510(k) NO: K180319(Traditional)
ATTN: Melissa Thomas PHONE NO : 585 3386045
1400 North Goodman Street SE DECISION MADE: 27-MAR-18
Rochester NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aesculap Optilene Nonabsorbable Suture
Aesculap, Inc. 510(k) NO: K180321(Special)
ATTN: Kathy A. Racosky PHONE NO : 610 9849291
3773 Corporate Parkway SE DECISION MADE: 07-MAR-18
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitrea Software Package; VSTP-001A
Canon Medical Systems Corporation 510(k) NO: K180323(Traditional)
ATTN: Paul Biggins PHONE NO : 81 287 266478
1385 Shimoishigami SE DECISION MADE: 30-MAR-18
Otawara JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: icobrain
icometrix 510(k) NO: K180326(Special)
ATTN: Dirk Smeets PHONE NO : 32 16 369000
Kolonel Begaultlaan 1b /12 SE DECISION MADE: 08-MAR-18
Leuven BE 3012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
Liofilchem s. r. l. 510(k) NO: K180330(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 15-MAR-18
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: LEGION Knee System
Smith & Nephew, Inc. 510(k) NO: K180334(Special)
ATTN: Michael Scott PHONE NO : 901 3991633
1450 Brooks Rd. SE DECISION MADE: 05-MAR-18
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accutension Smartphone Auscultatory Blood
Shanghai Hulu Devices Co., Ltd 510(k) NO: K180335(Third Party - Traditional)
ATTN: Jungeng Zhao PHONE NO : 86 186 21892190
No. 509 Caobao Road, Room 101-2 BlSE DECISION MADE: 08-MAR-18
Shanghai CN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Dornier Medilas H Solvo 35 Laser
Dornier MedTech America 510(k) NO: K180350(Special)
ATTN: John Hoffer PHONE NO : 770 5146163
1155 Roberts Blvd SE DECISION MADE: 07-MAR-18
Kennesaw GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voluson S8/ Voluson S10/ Voluson S10 Expert
GE Healthcare 510(k) NO: K180374(Special)
ATTN: Bryan Behn PHONE NO : 262 2475502
9900 Innovation Drive SE DECISION MADE: 13-MAR-18
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRO Computed Tomography (CT) X-ray System
Mobius Imaging, LLC 510(k) NO: K180393(Traditional)
ATTN: Norma LeMay PHONE NO : 978 3919644
2 Shaker Road SE DECISION MADE: 15-MAR-18
Shirley MA 01464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BrightMatter Plan 1.6.0
Synaptive Medical Inc. 510(k) NO: K180394(Traditional)
ATTN: Maham Ansari PHONE NO : 647 2433122
555 Richmond Street West, Suite 80SE DECISION MADE: 09-MAR-18
Toronto CA M5V 3B1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: miraDry System
Miramar Labs, Inc. 510(k) NO: K180396(Special)
ATTN: Cynthia Kada PHONE NO : 408 9408700
2790 Walsh Avenue SE DECISION MADE: 15-MAR-18
Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
3M Health Care 510(k) NO: K180404(Third Party - Traditional)
ATTN: Lam Duong PHONE NO : 651 7335945
2510 Conway Avenue SE DECISION MADE: 16-MAR-18
St. Paul MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FUJIFILM Endoscope Models EC-600HL and EC-600LS
FUJIFILM Corporation 510(k) NO: K180405(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 15-MAR-18
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ellipse Ydun
Ellipse A/S 510(k) NO: K180406(Special)
ATTN: Ole Kofod PHONE NO : 45 4517 6863
Agern Alle 11 SE DECISION MADE: 15-MAR-18
Horsholm DK DK-2970 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEMO 4D
Sorin Group Italia S.r.l. 510(k) NO: K180411(Special)
ATTN: Mauro Ercolani PHONE NO : 39 0161 487412
Via Crescentino sn SE DECISION MADE: 16-MAR-18
Saluggia IT 13040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Natus NeuroWorks
Natus Medical Incorporated DBA Exc510(k) NO: K180421(Special)
ATTN: Shane Sawall PHONE NO : 608 8298673
2568 Bristol Circle SE DECISION MADE: 14-MAR-18
Oakville CA L6H 5SI 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Empower H65
quanta system spa 510(k) NO: K180423(Special)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 376797
via Acquedotto 109 SE DECISION MADE: 15-MAR-18
Samarate (Va) IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Empower H35
Quanta System Spa 510(k) NO: K180426(Special)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 376797
Via Acquedotto, 109 SE DECISION MADE: 16-MAR-18
Samarate IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advincula Delineator Uterine Manipulator
CooperSurgical, Inc. 510(k) NO: K180429(Special)
ATTN: Roaida Johnson PHONE NO : 203 6015200 3325
95 Corporate Dr SE DECISION MADE: 14-MAR-18
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cortina [MAX] Lumbar Cage System
NeuroStructures, Inc. 510(k) NO: K180431(Traditional)
ATTN: Kathleen Wong PHONE NO : 949 3704497
16 Technology Drive, Suite 165 SE DECISION MADE: 22-MAR-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
BD 510(k) NO: K180438(Special)
ATTN: Brad Spring PHONE NO : 410 3164206
10865 Road to the Cure SE DECISION MADE: 20-MAR-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tumark Vision
SOMATEX Medical Technologies GmbH 510(k) NO: K180443(Special)
ATTN: Burkhard Jakob PHONE NO : 4930 319 822500
Rheinstr. 7d SE DECISION MADE: 22-MAR-18
Teltow DE 14513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter
Sorin Group Italia S.r.l 510(k) NO: K180448(Special)
ATTN: Luigi Vecchi PHONE NO : 011 39 053529811
86, Via Statale 12 Nord SE DECISION MADE: 15-MAR-18
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corvocet Biopsy System
Merit Medical Systems, Inc. 510(k) NO: K180450(Special)
ATTN: Angela Brady PHONE NO : 801 3164818
1600 W Merit Parkway SE DECISION MADE: 12-MAR-18
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bio-Medicus Adult Cannulae and Introducer
Medtronic Inc 510(k) NO: K180453(Special)
ATTN: Huda Yusuf PHONE NO : 763 5149521
8200 Coral Street NE SE DECISION MADE: 22-MAR-18
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bio-Medicus Adult Cannulae Kit
Medtronic Inc. 510(k) NO: K180456(Special)
ATTN: Huda Yusuf PHONE NO : 763 5149805
8200 Coral Street NE SE DECISION MADE: 22-MAR-18
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR
ECOTRON Co., Ltd 510(k) NO: K180473(Traditional)
ATTN: Sang Bond Lee PHONE NO : 82 2 20253760
Rm 504, Hanshin IT Tower II, 47, DSE DECISION MADE: 23-MAR-18
Seoul KR 153-712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CapLOX II® / TowerLOX® MIS Pedicle Screw System
Captiva Spine, Inc. 510(k) NO: K180475(Traditional)
ATTN: Jackie Ferro PHONE NO : 877 7725571
967 N. Alternate A1A, Suite 1 SE DECISION MADE: 19-MAR-18
Jupiter FL 33477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemosIL Factor XII Deficient Plasma
Instrumentation Laboratory Co. 510(k) NO: K180486(Special)
ATTN: Carol Marble PHONE NO : 781 8614467
180 Hartwell Road SE DECISION MADE: 22-MAR-18
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mission Lipid Panel Monitoring System
ACON Laboratories, Inc. 510(k) NO: K180504(Special)
ATTN: Qiyi Xie PHONE NO : 858 8758011
10125 Mesa Rim Road SE DECISION MADE: 28-MAR-18
San Diego CA 92121 510(k) STATEMENT
DEVICE: CorPath GRX System
Corindus, Inc. 510(k) NO: K180517(Special)
ATTN: Robert Lavado PHONE NO : 508 6533335 211
309 Waverley Oaks Road SE DECISION MADE: 29-MAR-18
Waltham MA 02452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovoStitch Pro Meniscal Repair System
Ceterix Orthopaedics, Inc. 510(k) NO: K180531(Special)
ATTN: Tarhan Kayihan PHONE NO : 650 3963478
6500 Kaiser Drive, Suite 120 SE DECISION MADE: 29-MAR-18
Fremont CA 94555 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voluson P6 and Voluson P8
GE Healthcare 510(k) NO: K180535(Special)
ATTN: Bryan Behn PHONE NO : 262 2475502
9900 Innovation Drive SE DECISION MADE: 29-MAR-18
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation Buttress Plate System
Zavation Medical Products LLC 510(k) NO: K180537(Traditional)
ATTN: Matt Jones PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 27-MAR-18
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: gammaCore Sapphire
electroCore, LLC 510(k) NO: K180538(Special)
ATTN: Mike Romaniw PHONE NO : 973 2900097
150 Allen Road, Suite 201 SE DECISION MADE: 30-MAR-18
Basking Ridge NJ 07920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PressureWire X
St. Jude Medical (now part of Abbo510(k) NO: K180558(Special)
ATTN: Josh Johnson PHONE NO : 651 7563767
One St. Jude Medical Drive SE DECISION MADE: 28-MAR-18
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ezee Retrieval
Genicon, Inc 510(k) NO: K180579(Special)
ATTN: Katlyn Kachman PHONE NO : 407 6574851
6869 Stapoint Court Suite 114 SE DECISION MADE: 19-MAR-18
Winter Park FL 32792 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-scan Brio
Esaote S.p.A 510(k) NO: K180592(Special)
ATTN: Massimo Polignano PHONE NO : 39 055 4229402
Via Enrico Melen 77 SE DECISION MADE: 30-MAR-18
Genova IT 16152 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 295
TOTAL WITH SUMMARIES 287
TOTAL WITH STATEMENTS 8
