510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2018
DEVICE: 3.0 Dynamic TiBase
TALLADIUM ESPANA, SL 510(k) NO: K162021(Traditional)
ATTN: ESTEBAN XAM-MAR PHONE NO : 0034 9 73289580
PLAZA UTXESA 7 SE DECISION MADE: 04-MAY-18
LLEIDA ES 25002 510(k) STATEMENT
DEVICE: Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
Foremount Enterprise Co, Ltd. 510(k) NO: K170663(Traditional)
ATTN: John Yang PHONE NO : 886 4 25618788
No. 17, Alley 15, Lane 5, Shenan SSE DECISION MADE: 11-MAY-18
Taichung City TW 42944 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GBR system
SURGIDENT 510(k) NO: K170697(Traditional)
ATTN: Duck-su Hur PHONE NO : 82 31 7372875
#209~210, Woolim Lion’s Valley, 27SE DECISION MADE: 24-MAY-18
Seongnam-si KR 13219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Arthroscopic Electrode (with Pencil)
Modern Medical Equipment Manufactu510(k) NO: K170703(Traditional)
ATTN: Jerry Cheung PHONE NO : 852 2420 9068
35-41 Tai Lin Pai Rd, Unit F 5th FSE DECISION MADE: 31-MAY-18
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fluorescence Mode
Carl Zeiss Suzhou Co., Ltd. 510(k) NO: K171007(Traditional)
ATTN: Huang XiaoDong PHONE NO : 86 512 8227 1388
Modern Industrial Square 3b No. 33SE DECISION MADE: 03-MAY-18
Suzhou CN 215126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ScioCardio ECG Transmitter
Synergen Technology Labs LLC 510(k) NO: K171019(Traditional)
ATTN: Sunil Konda PHONE NO : 214 4350633
3131 McKinney Avenue Suite 602 SE DECISION MADE: 30-MAY-18
Dallas TX 75204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Metacem
Meta Biomed Co., Ltd 510(k) NO: K171449(Traditional)
ATTN: Suk Song Oh PHONE NO : 82 43 2308959
270, Osong Saengmyeong 1-ro, OsongSE DECISION MADE: 15-MAY-18
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
Dimesol, Inc. 510(k) NO: K171505(Traditional)
ATTN: Stephen P. Callaghan PHONE NO : 717 9388391
509 Fishing Creek Road SE DECISION MADE: 17-MAY-18
Lewisberry PA 17339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smartcord, Smartcord X
EASTDENT Co., Ltd 510(k) NO: K171577(Traditional)
ATTN: Hyonsu Kim PHONE NO : 82 31 6935767
601-1 Sogong B/D, 64 Gugal-ro, GihSE DECISION MADE: 03-MAY-18
Yongin-si KR 16972 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trident Extremity Fixation System
Trident Orthopedics 510(k) NO: K171690(Traditional)
ATTN: Al Austin PHONE NO : 410 9039038
212 Copperwood Court SE DECISION MADE: 08-MAY-18
Millersville MD 21108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETCO2 Sensor
Orantech Inc. 510(k) NO: K171828(Traditional)
ATTN: Yunxi Xiong PHONE NO : 86 755 23699939
Zone#A,4F,1st Bld, 7th Industrial SE DECISION MADE: 31-MAY-18
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URIS OMNI System
TruAbutment Inc. 510(k) NO: K172100(Traditional)
ATTN: Brandon Kim PHONE NO : 714 9561488
300 South Harbor Blvd #520 SE DECISION MADE: 04-MAY-18
Anaheim CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIEZOTOME CUBE
Satelec - Acteon Group 510(k) NO: K172137(Traditional)
ATTN: Philippe Girard PHONE NO : 011 33 556340607
17 Avenue Gustave Eiffel SE DECISION MADE: 03-MAY-18
Merignac FR 33708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
Medela AG 510(k) NO: K172145(Traditional)
ATTN: Georges Hakim PHONE NO : 41 041 5621651
Lattichstrasse 4b SE DECISION MADE: 09-MAY-18
Baar CH 6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAR 65
Skanray Technologies Pvt Ltd 510(k) NO: K172147(Traditional)
ATTN: Mahadevan J PHONE NO : 91 821 2407000
#360, KIADB Industrial Area, HebbaSE DECISION MADE: 25-MAY-18
Mysore IN 570018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERIZONE VP4 Sterilizer
TSO3 Inc 510(k) NO: K172191(Traditional)
ATTN: Alexandre Jokic PHONE NO : 418 6510003 287
2505 Avenue Dalton SE DECISION MADE: 09-MAY-18
Quebec CA G1P 3S5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURA ICP MONITORING SYSTEM
Branchpoint Technologies, INC. 510(k) NO: K172209(Traditional)
ATTN: Nicholas Hu PHONE NO : 949 8291868
1 Technology Drive, Suite I-811 SE DECISION MADE: 18-MAY-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DripAssist Plus
Shift Labs, Inc. 510(k) NO: K172242(Traditional)
ATTN: Beth Kolko PHONE NO : 206 3691216
1600 Dexter Ave N, Suite A SE DECISION MADE: 25-MAY-18
Seattle WA 98109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trackit T4 EEG Amplifier
Lifelines Ltd. 510(k) NO: K172271(Traditional)
ATTN: Michael Hulin PHONE NO : 44 012 64782226
7 Clarendon Court SE DECISION MADE: 04-MAY-18
Over Wallop GB SO20 8HU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lite
Tzora Active Systems Ltd. 510(k) NO: K172409(Traditional)
ATTN: Adi Shemer PHONE NO : 972 2 9908207
SE DECISION MADE: 02-MAY-18
Kibbutz Tzora IL 9980300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BacterioScan 216Dx System
BacterioScan, Inc. 510(k) NO: K172412(Traditional)
ATTN: Rhonda Soest PHONE NO : 844 2227226
4041 Forest Park Ave. SE DECISION MADE: 01-MAY-18
St. Louis MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArgenIS Titanium Abutments
Argen Corporation 510(k) NO: K172430(Traditional)
ATTN: Paul Cascone PHONE NO : 1 858 4557900
5855 Oberlin Drive SE DECISION MADE: 18-MAY-18
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTANA CD30 (Ber-H2) RxDx Assay
Ventana Medical Systems, Inc. 510(k) NO: K172471(Traditional)
ATTN: Jeffrey Catania PHONE NO : 1 800 2272155
1910 E Innovation Park Dr SE DECISION MADE: 08-MAY-18
Tuscon AZ 87555 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: icotec Interbody Cage System
icotec ag 510(k) NO: K172480(Traditional)
ATTN: Valeria Consiero PHONE NO : 41 71 7570055
Industriestrasse 12 SE DECISION MADE: 17-MAY-18
9450 Altstaetten CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-CIFT SoloFuse
SpineFrontier, Inc. 510(k) NO: K172484(Traditional)
ATTN: Vito Lore PHONE NO : 978 2323990 275
350 Main Street 3rd Floor SE DECISION MADE: 08-MAY-18
Malden MA 02148 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: µCor Heart Failure and Arrhythmia Management System
ZOLL Manufacturing Corporation 510(k) NO: K172510(Traditional)
ATTN: Dawn Chang PHONE NO : 412 9683333 31815
121 Gamma Drive SE DECISION MADE: 11-MAY-18
Pittsburgh PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Navigation System
SeaSpine Orthopedics Corporation 510(k) NO: K172517(Traditional)
ATTN: Gina Flores PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 11-MAY-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Persona Personalized Knee System
Zimmer, Inc. 510(k) NO: K172524(Traditional)
ATTN: Nicole Meredith PHONE NO : 574 3773718
P.O. Box 708 SE DECISION MADE: 17-MAY-18
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
Huizhou Foryou Medical Devices Co.510(k) NO: K172554(Traditional)
ATTN: Huida Huang PHONE NO : 86 0752 5302185
North Shangxia Rd., Dongjiang Hi-tSE DECISION MADE: 01-MAY-18
Huizhou CN 516005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAPPHIRE, ELEVARE SAPPHIRE
Omm Imports, Inc. d/b/a Zero Gravi510(k) NO: K172555(Traditional)
ATTN: Zivan Habibi PHONE NO : 305 5275593
9737 NW 41St Street SE DECISION MADE: 01-MAY-18
Doral FL 33178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cervage
PRECIFIT MEDICAL LTD 510(k) NO: K172568(Traditional)
ATTN: Zhen Yu (Eric) Wu PHONE NO :
2233 5th Street East SE DECISION MADE: 04-MAY-18
St. Paul MN 55119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALGS6 Ag Alginate Wound Dressing
Foshan United Medical Technologies510(k) NO: K172570(Traditional)
ATTN: Una Chen PHONE NO : 0086 0757 89961126
89 Taoyuan East Road, Shishan, NanSE DECISION MADE: 11-MAY-18
Foshan CN 528225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern
Euroimmun US, Inc. 510(k) NO: K172582(Traditional)
ATTN: Michael A. Locke PHONE NO : 973 6561000
1 Bloomfield Avenue SE DECISION MADE: 24-MAY-18
Mountain Lakes NJ 07046 510(k) STATEMENT
DEVICE: OrthoPediatrics PediNail Intramedullary Platform
OrthoPediatrics, Inc. 510(k) NO: K172583(Traditional)
ATTN: Adam Cargill PHONE NO : 574 2686379
2850 Frontier Drive SE DECISION MADE: 10-MAY-18
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADD Yellow High Volume Administration Set with NRFit connector
Smiths Medical ASD, Inc. 510(k) NO: K172592(Traditional)
ATTN: Michael R. Johnson PHONE NO : 763 3833341
6000 Nathan Lane North SE DECISION MADE: 17-MAY-18
Minneapolis MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left
Caldera Medical, Inc. 510(k) NO: K172614(Traditional)
ATTN: Vicki Gail PHONE NO : 818 4837602
5171 Clareton Drive SE DECISION MADE: 04-MAY-18
Agoura Hills CA 91301 510(k) STATEMENT
DEVICE: Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
Nonin Medical Inc. 510(k) NO: K172625(Traditional)
ATTN: Kim E. Aves PHONE NO : 763 5773196
13700 1st Avenue North SE DECISION MADE: 11-MAY-18
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentium Implantium & SuperLine Prosthetics
Dentium Co., Ltd. 510(k) NO: K172640(Abbreviated)
ATTN: Sangpil Yoon PHONE NO : 82 31 2072200
150, Eondong-ro, Giheung-gu SE DECISION MADE: 14-MAY-18
Yongin-si KR 16985 510(k) STATEMENT
DEVICE: BiliLux
Draeger Medical Systems, Inc. 510(k) NO: K172656(Traditional)
ATTN: Gale Winarsky PHONE NO : 215 6602239
3135 Quarry Road SE DECISION MADE: 01-MAY-18
Telford PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fetzer Medical Gynecological Forceps
Fetzer Medical GmbH & Co. KG 510(k) NO: K172661(Traditional)
ATTN: Harald Jung PHONE NO : 49 7462 94799182
Unter Buchsteig 5 SE DECISION MADE: 08-MAY-18
Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
Wilson-Cook Medical, Inc. / Cook E510(k) NO: K172665(Traditional)
ATTN: Theresa de Prat PHONE NO : 336 7440157 396518
4900 Bethania Station Road SE DECISION MADE: 24-MAY-18
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Varian Cervical Sleeves
Varian Medical Systems, Inc. 510(k) NO: K172675(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 16-MAY-18
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ToFscan
Idmed 510(k) NO: K172690(Traditional)
ATTN: Frédéric BERNERT PHONE NO : 0033 49 1118784
Hotel Technoptic - 2 rue Marc DonaSE DECISION MADE: 31-MAY-18
Marseille FR 13013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2Bacteria Panel
T2 Biosystems, Inc. 510(k) NO: K172708(Traditional)
ATTN: Tom Lowery PHONE NO : 781 4571223
101 Hartwell Avenue SE DECISION MADE: 24-MAY-18
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automatic Tissue Processing Unit
BSL Co. 510(k) NO: K172717(Traditional)
ATTN: Jun Suk Lee PHONE NO : 82 55 3289235
6-13, Chilsan-ro 237 beon-gil SE DECISION MADE: 25-MAY-18
Gimhae-Si KR 51006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HealthBeacon HB2 Sharps Bin
HealthBeacon Ltd 510(k) NO: K172719(Traditional)
ATTN: Joyce Power PHONE NO : 353 1 4508480
Unit 20, Naas Road Business Park, SE DECISION MADE: 11-MAY-18
Dublin IE Dublin 12 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polypectomy Snare
Hangzhou AGS MedTech CO., Ltd 510(k) NO: K172729(Traditional)
ATTN: Chunqi Han PHONE NO : 86 571 87671223
Building 6, Kangxin Road No.597 QiSE DECISION MADE: 21-MAY-18
Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
PAJUNK GmbH Medizintechnologie 510(k) NO: K172777(Traditional)
ATTN: Christian G. H. Quass PHONE NO : 49 7704 9291586
Karl-Hall-Str. 1 SE DECISION MADE: 03-MAY-18
Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Esophageal Stent System
Micro-Tech (Nanjing) Co.,Ltd. 510(k) NO: K172813(Traditional)
ATTN: Becky Li PHONE NO : 86 25 58646378
No.10 Gaoke Third Road SE DECISION MADE: 18-MAY-18
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MN-111
W&H Sterilization s.r.l. 510(k) NO: K172825(Traditional)
ATTN: Marco Parolini PHONE NO : 39 035 6663000
Via Bolgara, 2 SE DECISION MADE: 30-MAY-18
Brusaporto IT 510(k) STATEMENT
DEVICE: Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Maxter Glove Manufacturing Sdn Bhd510(k) NO: K172864(Traditional)
ATTN: Yap Peak Geeh PHONE NO : 603 614 52328
Lot 6070, Jalan Haji Abdul Manah 6SE DECISION MADE: 02-MAY-18
Klang MY 41050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
GMP MEDICARE SDN BHD (F25) 510(k) NO: K172867(Traditional)
ATTN: Noraini Raus PHONE NO : 603 33926317
LOT/PT64593, JLN Dahlia/KU8, KAW PSE DECISION MADE: 10-MAY-18
Klang MY 41050 510(k) STATEMENT
DEVICE: SpineKure Kyphoplasty System
Hanchang Co., Ltd. 510(k) NO: K172871(Traditional)
ATTN: An Kwon Ho PHONE NO : 82 32 2340033
#301-204 Bucheon Techno-park 345, SE DECISION MADE: 29-MAY-18
Bucheon-si KR 14501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UINCARE HOME
UINCARE Corp. 510(k) NO: K172882(Traditional)
ATTN: Youngbean You PHONE NO : 82 2 62650944
A-603, 131, Gasan digital 1-ro SE DECISION MADE: 10-MAY-18
Geumcheon-gu KR 08506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Shenzhen Pacom Medical Instruments510(k) NO: K172889(Traditional)
ATTN: Liangzhou Zhong PHONE NO : 86 755 32920339
8 Floor, B District, B Building, NSE DECISION MADE: 25-MAY-18
Shenzhen CN 518105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Shenzhen Jiacom Technology Co ., L510(k) NO: K172894(Traditional)
ATTN: Luo Tianfeng PHONE NO : 86 755 29015600
No. A6 Building, Silicon Valley PoSE DECISION MADE: 17-MAY-18
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PeraServer and PeraTrend
PeraHealth, Inc. 510(k) NO: K172959(Traditional)
ATTN: Joseph Beals PHONE NO : 401 4000401
6302 Fairview Rd.,Suite 310 SE DECISION MADE: 01-MAY-18
Charlotte NC 28210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Micropuncture Pedal Access Set
Cook Incorporated 510(k) NO: K172980(Traditional)
ATTN: Daniel J Corbin PHONE NO : 812 3353575 104018
750 Daniels Way SE DECISION MADE: 03-MAY-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SB Soft Hood - Straight type, SB Soft Hood - Undercut type
Sumitomo Bakelite Co., Ltd 510(k) NO: K173004(Traditional)
ATTN: Shiro Agehama PHONE NO : 81 3 54624811
5-8, Higashi-Shinagawa 2-chome SE DECISION MADE: 08-MAY-18
Shinagawa-ku JP 1400002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURECELL Gelling Fiber Wound Dressing
Jiangsu Newvalue Medical Producst 510(k) NO: K173005(Traditional)
ATTN: Julie Chen PHONE NO : 86 21 50211200 201
Building G35.the east of KouTai RoSE DECISION MADE: 25-MAY-18
TaiZhou CN 225300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIO-PRESS LITE DVT Compression Device
Pegasus Medical Supply, Inc. 510(k) NO: K173012(Traditional)
ATTN: Pao-Ming Shih PHONE NO : 886 3 2753341
No. 27-1, Ln. 473, Sec. 2, Hezun NSE DECISION MADE: 10-MAY-18
Taoyuan County TW 32060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
Cook Incorporated 510(k) NO: K173035(Traditional)
ATTN: Erum B. Nasir PHONE NO : 812 3353575 102607
750 Daniels Way SE DECISION MADE: 01-MAY-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectrum IQ Infusion System, Dose IQ Safety Software
Baxter Healthcare Corporation 510(k) NO: K173084(Traditional)
ATTN: Dhiraj Bizzul PHONE NO : 224 2702177
32650 N. Wilson Road SE DECISION MADE: 11-MAY-18
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smoklean
Sejong Medical Co., Ltd. 510(k) NO: K173108(Traditional)
ATTN: Yoojung Choi PHONE NO : 82 31 9458191
11, Sinchon 2-ro SE DECISION MADE: 18-MAY-18
Paju-si KR 10880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAFTSITE
Summit Medical Ltd. 510(k) NO: K173110(Traditional)
ATTN: Robyn Cochrane PHONE NO : 44 0 1451821311
Bourton Industrial Park SE DECISION MADE: 18-MAY-18
Bourton on the Water GB gl54 2hq 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dr's Light2
Good Doctors Co.,Ltd. 510(k) NO: K173157(Traditional)
ATTN: Sungro Joo PHONE NO : 82 32 4246325
#208, B-Dong, 283 Bupyeong-Daero, SE DECISION MADE: 29-MAY-18
Incheon KR 21315 510(k) STATEMENT
DEVICE: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
Sekisui Medical Co., Ltd. 510(k) NO: K173202(Traditional)
ATTN: Kazunori Saito PHONE NO : 81 3 32720674
1-3 Nihonbashi 2-Chome SE DECISION MADE: 09-MAY-18
Chuo-Ku JP 103-00227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANEROID SPHYGMOMANOMETER
Wenzhou Bokang Instruments Co., Lt510(k) NO: K173246(Abbreviated)
ATTN: Youhua Xiang PHONE NO : 86 577 86876969
No. 1500 Haining Road, Haibin LongSE DECISION MADE: 30-MAY-18
Wenzhou CN 325024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EmbryoScope+
Vitrolife A/S 510(k) NO: K173264(Traditional)
ATTN: Belinda Dueholm PHONE NO : 45 72 217900
Jens Juuls Vej 20 SE DECISION MADE: 11-MAY-18
Viby J DK 8260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KATOR Suture Anchor
KATOR LLC 510(k) NO: K173269(Traditional)
ATTN: Robert Hoy PHONE NO : 614 4486358
124 South 600 West, Suite 100 SE DECISION MADE: 30-MAY-18
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
MYCO Medical Supplies, Inc. 510(k) NO: K173279(Traditional)
ATTN: Sanjiv Kumar PHONE NO : 919 4602535
2015 Production Drive SE DECISION MADE: 14-MAY-18
Apex NC 27539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magnesium
Abbott Laboratories 510(k) NO: K173294(Traditional)
ATTN: Kimberly Senseman PHONE NO : 972 5186854
1921 Hurd Drive SE DECISION MADE: 18-MAY-18
Irving TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViaTherm BOOST
ViaTherm Therapeutics, Llc. 510(k) NO: K173300(Traditional)
ATTN: Michael J. Thomas PHONE NO : 410 7775251
201 Defense Highway Suite 260 SE DECISION MADE: 01-MAY-18
Annapolis MD 21401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Faxitron VisionCT
Faxitron Bioptics Llc 510(k) NO: K173309(Traditional)
ATTN: Douglas C. Wiegman PHONE NO : 520 3998180
3440 E. Britannia Dr. Suite 150 SE DECISION MADE: 09-MAY-18
Tucson AZ 85706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHRO-Pump PA304
W.O.M. World of Medicine GmbH 510(k) NO: K173311(Traditional)
ATTN: Soeren Markworth PHONE NO : 0049 30 39981594
Salzufer 8 SE DECISION MADE: 09-MAY-18
Berlin DE 10587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
TaiDoc Technology Corporation 510(k) NO: K173345(Traditional)
ATTN: Sheena Song PHONE NO : 88 626 6258188 1158
B1-7F, No. 127, Wugong 2nd Rd., WuSE DECISION MADE: 04-MAY-18
New Taipei City TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX
Centinel Spine, Inc. 510(k) NO: K173347(Traditional)
ATTN: Jessica Staub PHONE NO : 484 8878803
900 Airport Road, Suite 3B SE DECISION MADE: 08-MAY-18
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Athena 190
Medical Rehab Products, LLC 510(k) NO: K173360(Traditional)
ATTN: Brad Evans PHONE NO : 706 2016186
PO BOX 1182 SE DECISION MADE: 17-MAY-18
Montreat NC 28757 510(k) STATEMENT
DEVICE: OsteoMed QuickFix Hybrid MMF Sterilization Tray
OsteoMed LLC 510(k) NO: K173391(Traditional)
ATTN: Jessica M. Ruperto PHONE NO : 972 6774795
3885 Arapaho Rd SE DECISION MADE: 10-MAY-18
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECALL CLISIS SYSTEMS, Discovery RF180
General Medical Merate S.P.A 510(k) NO: K173395(Special)
ATTN: Luca Bianchessi PHONE NO : 39 035 4525396
Via Partigiani, 25 SE DECISION MADE: 21-MAY-18
Seriate IT 24068 510(k) STATEMENT
DEVICE: DiLumen Endolumenal Interventional Scissors (DiLumen Is)
Lumendi, LLC 510(k) NO: K173405(Traditional)
ATTN: Dennis Daniels PHONE NO : 203 4632669
253 Post Road West SE DECISION MADE: 22-MAY-18
Westport CT 06880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoWrist 5mm Thoracic Grasper
Intuitive Surgical, Inc. 510(k) NO: K173415(Traditional)
ATTN: Gayle Perry PHONE NO : 408 5232100
1266 Kifer Road SE DECISION MADE: 31-MAY-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Towako Transmyometrial Embryo Transfer Set
William A. Cook Australia PTY LTD 510(k) NO: K173431(Special)
ATTN: Gordana Pozvek PHONE NO : 61 7 38411188
95 Brandl Street SE DECISION MADE: 18-MAY-18
Eight Mile Plains AU 4113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EmboTrap ll Revascularization Device
Neuravi Ltd. 510(k) NO: K173452(Traditional)
ATTN: Mairsil Claffey PHONE NO : 353 91 394121
Block 3, Ballybrit Business Park SE DECISION MADE: 09-MAY-18
Galway IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pure Flow External Counter-Pulsation Device
Xtreem Pulse, LLC 510(k) NO: K173483(Traditional)
ATTN: Andrew Barile PHONE NO : 212 6439062
353 W 29 St., Suite 3 SE DECISION MADE: 30-MAY-18
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioStamp nPoint
MC10 Inc. 510(k) NO: K173510(Traditional)
ATTN: Rakesh Lal PHONE NO : 857 2145600
10 Maguire Road Bldg 3 First FloorSE DECISION MADE: 08-MAY-18
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainsway Deep (DTMS) System
Brainsway Ltd. 510(k) NO: K173540(Traditional)
ATTN: Ahava Stein PHONE NO : 972 2 5824030
19 Hartom Str. SE DECISION MADE: 03-MAY-18
Jerusalem IL 9777518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DSM Biomedical Calcium Phosphate Cement with Microspheres
Kensey Nash Corporation dba DSM Bi510(k) NO: K173572(Traditional)
ATTN: Susan Pileggi PHONE NO : 484 7132173
735 Pennsylvania Drive SE DECISION MADE: 09-MAY-18
Exton PA 19431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pristina Serena
GE Healthcare 510(k) NO: K173576(Traditional)
ATTN: Gregory Pessato PHONE NO : 33 1 30709316
283 rue de la Miniere SE DECISION MADE: 14-MAY-18
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch
Fresenius Medical Care Renal Thera510(k) NO: K173593(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 6994479
920 Winter Street SE DECISION MADE: 21-MAY-18
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
Alere Scarborough, Inc. 510(k) NO: K173653(Dual Track)
ATTN: Danielle A. Briggeman PHONE NO : 207 7305750 65925
10 Southgate Road SE DECISION MADE: 02-MAY-18
Scarborough ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
Medical Components, Inc. (Dba Medc510(k) NO: K173667(Traditional)
ATTN: Courtney Nix PHONE NO : 215 2564201
1499 Delp Drive SE DECISION MADE: 17-MAY-18
Harleysville PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: g.Estim PRO
g.tec medical engineering GmbH 510(k) NO: K173684(Third Party - Traditional)
ATTN: Christoph Guger PHONE NO : 43 7251 222400
Siemingerstrasse 14 SE DECISION MADE: 04-MAY-18
Schiedlberg AU 4521 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Wallaby Avenir Coil System
Wallaby Medical, Inc. 510(k) NO: K173711(Traditional)
ATTN: Rebecca K. Pine PHONE NO : 760 8095178
23181 Verdugo Dr. SE DECISION MADE: 04-MAY-18
Laguna Hills CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liberty Cycler Set
Fresenius Medical Care Renal Thera510(k) NO: K173718(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 6994479
920 Winter Street SE DECISION MADE: 01-MAY-18
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATRIOT COLONIAL Spacer, SUSTAIN Spacer
Globus Medical Inc. 510(k) NO: K173722(Traditional)
ATTN: Kelly Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 23-MAY-18
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Biopsy Valve
Zhejiang Chuangxiang Medical Techn510(k) NO: K173758(Traditional)
ATTN: Lucius Long PHONE NO : 86 571 89167088 8187
301B, No.22, XinYan Road SE DECISION MADE: 14-MAY-18
Hanzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accu O2 Oxygen Analyzer
Precision Medical Inc. 510(k) NO: K173807(Abbreviated)
ATTN: James Parker PHONE NO : 610 2626090
300 Held Drive SE DECISION MADE: 02-MAY-18
Northampton PA 18067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ventripoint Medical System Plus (VMS+)
Ventripoint Diagnostics, Ltd. 510(k) NO: K173810(Traditional)
ATTN: Desmond Hirson PHONE NO : 416 8480709
2 Sheppard Avenue East, Suite 605 SE DECISION MADE: 14-MAY-18
Toronto CA M2N 5Y7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MC 300R* Nebulizer
Trudell Medical International 510(k) NO: K173825(Traditional)
ATTN: Marianne Tanton PHONE NO : 519 4557060
725 Third Street SE DECISION MADE: 02-MAY-18
London CA n5V 5G4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glidesheath Slender
Terumo Medical Corporation 510(k) NO: K173831(Traditional)
ATTN: Liang Lu PHONE NO : 410 3927321
950 Elkton Blvd SE DECISION MADE: 08-MAY-18
Elkton MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InTice™-C Porous Ti Cervical Interbody System
X-Spine Systems, Inc. 510(k) NO: K173832(Traditional)
ATTN: Charlene Brumbaugh PHONE NO : 937 8478400 2192
452 Alexandersville Rd. SE DECISION MADE: 17-MAY-18
Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Pump Console
Spectrum Medical Ltd 510(k) NO: K173834(Traditional)
ATTN: Mark Drain PHONE NO : 44 0 1242650120
Harrier 4, Meteor Business Park, CSE DECISION MADE: 25-MAY-18
Gloucester GB GL2 9QL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Drug Relief
DyAnsys, Inc. 510(k) NO: K173861(Traditional)
ATTN: San Mateo PHONE NO : 408 4804700
300 North Bayshore Boulevard SE DECISION MADE: 02-MAY-18
San Mateo CA 94401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pantheris System
Avinger, Inc. 510(k) NO: K173862(Traditional)
ATTN: Thomas Lawson PHONE NO : 650 2417004
400 Chesapeake Drive SE DECISION MADE: 22-MAY-18
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
Origami Surgical LLC 510(k) NO: K173874(Traditional)
ATTN: John Gillespie PHONE NO : 973 7656256
42 Main St. Suite A SE DECISION MADE: 04-MAY-18
Madison NJ 07945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive® XLX Interbody System
NuVasive, Incorporated 510(k) NO: K173892(Traditional)
ATTN: Cynthia Adams PHONE NO : 858 3204549
7475 Lusk Blvd. SE DECISION MADE: 04-MAY-18
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyoSure MANUAL Tissue Removal Device
Hologic, Inc. 510(k) NO: K173901(Traditional)
ATTN: Anne-Marie Keefe PHONE NO : 508 2638851
250 Campus Drive SE DECISION MADE: 08-MAY-18
Marlbrough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
Intuitive Surgical, Inc. 510(k) NO: K173906(Traditional)
ATTN: Elaine Lee PHONE NO : 408 5238887
1266 Kifer Road SE DECISION MADE: 31-MAY-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
Smiths Medical ASD, Inc. 510(k) NO: K173912(Traditional)
ATTN: Donna M. Semlak PHONE NO : 763 3833076
6000 Nathan Lane North SE DECISION MADE: 08-MAY-18
Minneapolis MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD® Imaging Bulk Package Transfer Set
Bayer U.S. LLC 510(k) NO: K173913(Traditional)
ATTN: Leslie S. O'Nan PHONE NO : 412 4063165
1 Bayer Drive SE DECISION MADE: 04-MAY-18
Indianola PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VORTRAN Cuff Inflator (VCI)
VORTRAN Medical Technology 1, Inc.510(k) NO: K173914(Traditional)
ATTN: James Lee PHONE NO : 916 6488460 15
21 Goldenland Court #100 SE DECISION MADE: 25-MAY-18
Sacramento CA 95834 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MindMotion(TM) GO
MindMaze SA 510(k) NO: K173931(Traditional)
ATTN: Sylvian Bourriquet PHONE NO : 41 21 5520807
Chemin de Roseneck 5 SE DECISION MADE: 17-MAY-18
Lausanne CH CH-1006 510(k) STATEMENT
DEVICE: IS-III Bioactive Fixture
Neobiotech Co., Ltd. 510(k) NO: K173938(Traditional)
ATTN: Young-Ko Heo PHONE NO : 82 2 5822885
#312-1, 36, Digital-ro 27-gil, GurSE DECISION MADE: 24-MAY-18
Seoul KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Astroid Planning App
.decimal, LLC. 510(k) NO: K173940(Traditional)
ATTN: Kevin Erhart PHONE NO : 407 3303300
121 Central Park Place SE DECISION MADE: 15-MAY-18
Sanford FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAPT for Gamma3
Stryker GmbH 510(k) NO: K173946(Traditional)
ATTN: Nesli Karakaya PHONE NO : 41 32 6416930
Bohnackerweg 1 SE DECISION MADE: 02-MAY-18
Selzach CH 2545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Legend Acetabular Liners
Ortho Development Corporation 510(k) NO: K173951(Special)
ATTN: Drew Weaver PHONE NO : 801 6193419
12187 South Business Park Drive SE DECISION MADE: 30-MAY-18
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biowy PlCC Catheter
Biowy Corporation 510(k) NO: K173956(Traditional)
ATTN: Andre von Muller PHONE NO : 1 949 3058211
27031/27002 Vista Terrace SE DECISION MADE: 21-MAY-18
Lake Forest CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2008T BlueStar Hemodialysis Machine
Fresenius Medical Care Renal Thera510(k) NO: K173972(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 6994479
920 Winter Street SE DECISION MADE: 10-MAY-18
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORE-SIGHT ELITE Module Tissue Oximeter
CAS Medical Systems, Inc. 510(k) NO: K180003(Traditional)
ATTN: Ron Jeffrey PHONE NO : 203 4886056
44 East Industrial Road SE DECISION MADE: 10-MAY-18
Branford CT 06405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAAS Workstation
Pie Medical Imaging BV 510(k) NO: K180019(Traditional)
ATTN: Annemiek Bouts PHONE NO : 31 43 3281328
Philipsweg 1 SE DECISION MADE: 03-MAY-18
Maastricht NL 6227 AJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cook 810 Set, Desilets-Hoffman Introducer Set
Cook Incorporated 510(k) NO: K180028(Traditional)
ATTN: Carly Powell PHONE NO : 812 3392235 104913
750 Daniels Way SE DECISION MADE: 02-MAY-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endopath Electrosurgery Probe Plus II
Ethicon Endo-Surgery, LLC 510(k) NO: K180031(Traditional)
ATTN: Carmen Ortiz PHONE NO : 787 2726500
475 Calle C SE DECISION MADE: 07-MAY-18
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Weinmann Tracheostomy Exchange Set
Cook Incorporated 510(k) NO: K180034(Traditional)
ATTN: Paul Meyer PHONE NO : 812 3392235 105299
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 07-MAY-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XSTAT 30, 1-Pack
RevMedx, Inc. 510(k) NO: K180051(Traditional)
ATTN: Amy K. Pointer PHONE NO : 503 2182172
25999 SW Canyon Creek Road, Suite SE DECISION MADE: 18-MAY-18
Wilsonville OR 97070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STYLO Interbody Fusion Device
Legend Spine Technologies 510(k) NO: K180071(Traditional)
ATTN: Gwendolyn DeBoer PHONE NO : 610 3660077
1803 Apple Tree Lane SE DECISION MADE: 03-MAY-18
Bethlehem PA 18015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
Hill-Rom Inc. 510(k) NO: K180079(Traditional)
ATTN: Sarah Marie Fitzgerald PHONE NO : 812 9312924
1069 State Route 46 East SE DECISION MADE: 07-MAY-18
Batesville IN 47006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A.M. Surgical Intramedullary Fixation Device
A.M. Surgical, Inc 510(k) NO: K180087(Traditional)
ATTN: Gavriel Feuer PHONE NO : 631 6566410
222 Middle Country Road Suite 202 SE DECISION MADE: 18-MAY-18
Smithtown NY 11787 510(k) STATEMENT
DEVICE: HEALIX ADVANCE KNOTLESS BR Anchor
Medos International SARL 510(k) NO: K180101(Traditional)
ATTN: Ashley Goncalo PHONE NO :
Chemin-Blanc 38, Case Postale SE DECISION MADE: 10-MAY-18
Le Locle CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearGuard HD Antimicrobial Barrier Cap
Pursuit Vascular, Inc. 510(k) NO: K180111(Traditional)
ATTN: Douglas Killion PHONE NO : 612 4249006
6901 East Fish Lake Road, Suite 16SE DECISION MADE: 25-MAY-18
Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QT ECG
QT Medical, Inc. 510(k) NO: K180157(Traditional)
ATTN: Ruey-Kang Chang PHONE NO : 1 424 5583500
1001 W Carson Street Suite U SE DECISION MADE: 04-MAY-18
Torrance CA 90502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VivaScope System
Caliber Imaging & Diagnostics, Inc510(k) NO: K180162(Special)
ATTN: Joel Radford PHONE NO : 585 2399800
50 Methodist Hill Dr. Suite 1000 SE DECISION MADE: 03-MAY-18
Rochester NY 14623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TransEnterix Senhance Surgical System
TransEnterix, Inc. 510(k) NO: K180163(Traditional)
ATTN: Stephanie Fitts PHONE NO : 1 919 7658430
635 Davis Drive, Suite 300 SE DECISION MADE: 25-MAY-18
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Playtex Stella Tampons
Playtex Manufacturing, Inc. 510(k) NO: K180167(Traditional)
ATTN: Ludjane Fiorillo PHONE NO : 201 7858047
804 Walker Road SE DECISION MADE: 30-MAY-18
Dover DE 19904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Belun Ring
Belun Technology Company Limited 510(k) NO: K180174(Traditional)
ATTN: Leung Lap Wai Lydia PHONE NO : 852 3706 5640
Rm531B, floor 5, Core Building 2, SE DECISION MADE: 29-MAY-18
Sha Tin HK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erchonia FX-635
Erchonia Corporation 510(k) NO: K180197(Traditional)
ATTN: Steven Shanks PHONE NO : 321 4731251
650 Atlantis Rd. SE DECISION MADE: 21-MAY-18
Melbourne FL 32904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Route 92 Medical Access System
Route 92 Medical, Inc. 510(k) NO: K180201(Traditional)
ATTN: Kirsten Valley PHONE NO : 650 2798427
1700 S EI Camino Real Suite 206 SE DECISION MADE: 23-MAY-18
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Repris Bladder Injection System
URO-1, Inc. 510(k) NO: K180214(Traditional)
ATTN: Thomas Lawson PHONE NO : 336 9305456
391 Technology Way Suite 168 SE DECISION MADE: 03-MAY-18
Winston Salem NC 27101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VESTEX Apparel
Vestagen Protective Technologies, 510(k) NO: K180217(Traditional)
ATTN: Scott Pease PHONE NO : 407 7812572
1301 W. Colonial Dr. SE DECISION MADE: 18-MAY-18
Orlando FL 32804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAGICO OSI Spinal System by Osimplant
Spinal Analytics & Geometrical Imp510(k) NO: K180220(Traditional)
ATTN: James J Gibson Jr. PHONE NO : 813 8303636
2189 W Busch Blvd SE DECISION MADE: 21-MAY-18
Tampa FL 33612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Additive Orthopaedics Patient Specific 3D Printed Bone Segments
Additive Orthopaedics, LLC 510(k) NO: K180239(Traditional)
ATTN: Gregory Kowalczyk PHONE NO : 732 8826633
83 Amelia Circle SE DECISION MADE: 16-MAY-18
Little Silver NJ 07739 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Needle for Single Use
Jiangsu Shenli Medical Production 510(k) NO: K180259(Traditional)
ATTN: Tina Cai PHONE NO : 86 519 88731071
No 20, Changzheng Road, Zhenglu SE DECISION MADE: 18-MAY-18
Changzhou City CN 213111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Gold Standard Diagnostics 510(k) NO: K180264(Traditional)
ATTN: Napoleon Monce PHONE NO : 530 7598000
2851 Spafford St. SE DECISION MADE: 02-MAY-18
Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cellvizio 100 Series Systems with Confocal Miniprobes
Mauna Kea Technologies 510(k) NO: K180270(Traditional)
ATTN: Veronique Dentan PHONE NO : 33 170 080994
9 Rue d'Enghien SE DECISION MADE: 22-MAY-18
Paris FR 75010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silk'n MODEL H5003 device
Home Skinovations Ltd. 510(k) NO: K180279(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 09-MAY-18
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GSI Corti
Grason-Stadler Inc. 510(k) NO: K180287(Traditional)
ATTN: Amy Yanta PHONE NO : 952 9476097
10395 West 70th Street SE DECISION MADE: 11-MAY-18
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Retia 2
CenterVue SpA 510(k) NO: K180293(Traditional)
ATTN: Roberto Gabriotti PHONE NO : 39 049 5018399
Via S. Marco 9H SE DECISION MADE: 30-MAY-18
Padova IT 35129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Afinion HbA1c Dx
Alere Technologies AS 510(k) NO: K180296(Traditional)
ATTN: Monica Vallestad PHONE NO : 47 2405 6000
Kjelsaasveien 161 SE DECISION MADE: 07-MAY-18
Oslo NO NO-0884 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apollo TMS Therapy System
Mag & More GmbH 510(k) NO: K180313(Abbreviated)
ATTN: Kerstin Haringer PHONE NO : 49 89 20185248
Machtlfinger Strasse l3 SE DECISION MADE: 04-MAY-18
Munich DE 81379 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
MicroPort Orthopedics, Inc. 510(k) NO: K180317(Traditional)
ATTN: Grace Johnson-Bann PHONE NO : 901 2905904
5677 Airline Road SE DECISION MADE: 04-MAY-18
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7D Surgical System
7D Surgical Inc. 510(k) NO: K180352(Special)
ATTN: Daniel Ziskind PHONE NO : 647 4840079
60 Scarsdale Road, Unit 118 SE DECISION MADE: 02-MAY-18
Toronto CA M3B 2R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: inui In-Home Urine Analysis Test System
Scanadu, Inc. 510(k) NO: K180356(Traditional)
ATTN: Daya Ranamukhaarachchi PHONE NO : 301 5691213
1196 Borregas Ave., Ste 200 SE DECISION MADE: 25-MAY-18
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OKTAGON Implant System
Hager & Meisinger GmbH 510(k) NO: K180360(Traditional)
ATTN: Adam Tomczak PHONE NO : 0049 2131 20120
Hansemannstrasse 10 SE DECISION MADE: 10-MAY-18
Neuss DE 41468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRORAPTOR REGENESORB Suture Anchor
Smith and Nephew, Inc 510(k) NO: K180361(Traditional)
ATTN: Katherine Marcaccio PHONE NO : 508 2613602
7135 Goodlett Farms Parkway SE DECISION MADE: 30-MAY-18
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The IQoolTM Warm System
Brain Cool AB 510(k) NO: K180375(Traditional)
ATTN: Martin Waleij PHONE NO : 46 733 937076
Scheelevägen 2 SE DECISION MADE: 18-MAY-18
Medicon Village SE SE-223 81 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Light based hair removal device
Shenzhen GSD Tech Co., Ltd 510(k) NO: K180383(Traditional)
ATTN: Ziyi Gui PHONE NO : 86 755 29169431 8040
Building A Junsd Hi-Tech Park, WesSE DECISION MADE: 11-MAY-18
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Body Thermometer
HeTaiDa Technology Co., Ltd. 510(k) NO: K180385(Traditional)
ATTN: Tom Chen PHONE NO : 86 020 82245821
4F, BaiShiDa High-Tech Park, XiangSE DECISION MADE: 11-MAY-18
Foshan City CN 523820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Meron Plus QM
Voco GmbH 510(k) NO: K180386(Traditional)
ATTN: M. Th. Plaumann PHONE NO : 49 4721 7190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 08-MAY-18
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
Topcon Medical Laser Systems, Inc.510(k) NO: K180402(Traditional)
ATTN: Sweta Srivastava PHONE NO : 925 2457721
606 Enterprise Ct. SE DECISION MADE: 25-MAY-18
Livermore CA 94550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length
Ethicon Endo-Surgery, LLC 510(k) NO: K180403(Traditional)
ATTN: Sigfrido Delgado PHONE NO : 787 2726500
475 Calle C SE DECISION MADE: 23-MAY-18
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS40 Diagnostic Ultrasound System
Samsung Medison Co, Ltd. 510(k) NO: K180409(Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 2 21941594
3366, Hanseo-ro, Nam-myeon, HongchSE DECISION MADE: 11-MAY-18
Gangwon-do KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump Canister
Penumbra, Inc. 510(k) NO: K180412(Traditional)
ATTN: Richard Kimura PHONE NO : 510 9952034
One Penumbra Place SE DECISION MADE: 15-MAY-18
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPX-4440FN Digital Video Processor with Light Source
FUJIFILM New Development U.S.A., I510(k) NO: K180414(Traditional)
ATTN: Stephen Mariano PHONE NO : 781 8602463
318 Bear Hill Road SE DECISION MADE: 24-MAY-18
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hexanium® TLIF
SpineVision, SAS 510(k) NO: K180437(Traditional)
ATTN: Anaella Gallego PHONE NO : 33 1 53332525
10 Rue de la Renaissance, BatimentSE DECISION MADE: 04-MAY-18
Antony FR 92160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: reVive Light Therapy LED Ultrasonic Wrinkle System
LED Technologies, Inc. 510(k) NO: K180445(Traditional)
ATTN: Lloyd Nelson PHONE NO : 303 6460543 117
6000 Greenwood Plaza Blvd., Suite SE DECISION MADE: 15-MAY-18
Greenwood Village CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuralBot
Neural Analytics, Inc. 510(k) NO: K180455(Traditional)
ATTN: Javad Seyedzadeh PHONE NO : 914 4731678
2440 S Sepulveda Blvd. Suite 115 SE DECISION MADE: 22-MAY-18
Los Angeles CA 90064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Theradome LH40
Theradome, Inc. 510(k) NO: K180460(Traditional)
ATTN: Tamim Hamid PHONE NO : 510 7140525
4900 Hopyard Road, Suite 100 SE DECISION MADE: 18-MAY-18
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navi e/Navi s/Navi X Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technolog510(k) NO: K180461(Traditional)
ATTN: Jiang Xiaosan PHONE NO : 86 755860 077888003
1st and 5th Floor,No. 6 Building PSE DECISION MADE: 09-MAY-18
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEVUMED PHANTOM Suture Anchors
Aevumed, Inc. 510(k) NO: K180464(Traditional)
ATTN: Saif Khalil PHONE NO : 610 7457284
877 Richards Road SE DECISION MADE: 31-MAY-18
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowTriever Catheter, 6-10 mm; FlowTreiver Catheter, 11-14 mm; FlowTreiver Catheter, 15-18 mm; Aspiration Guide Catheter; Retraction Aspirator
Inari Medical 510(k) NO: K180466(Traditional)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Road Suite 124 SE DECISION MADE: 17-MAY-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Comfort Rubber Gloves Industries S510(k) NO: K180476(Traditional)
ATTN: Chan Yew Men PHONE NO : 605 8472777
Lot 821, Jalan Matang SE DECISION MADE: 15-MAY-18
Matang MY 34750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATEC Universal Spacer System
Alphatec Spine, Inc 510(k) NO: K180480(Traditional)
ATTN: Jeremy Markovich PHONE NO : 760 4946893
5818 El Camino Real SE DECISION MADE: 31-MAY-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOULE SYSTEM
Sciton, Inc. 510(k) NO: K180508(Traditional)
ATTN: Jay M/ Patel PHONE NO : 650 5438348
925 Commercial Street SE DECISION MADE: 18-MAY-18
Palo Alto CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CustomizedBone Service
Fin-Ceramica Faenza S.p.A 510(k) NO: K180513(Traditional)
ATTN: Marina Monticelli PHONE NO : 0039 0546 607311
via Ravegnana 186 SE DECISION MADE: 15-MAY-18
Faenza IT 48018 510(k) STATEMENT
DEVICE: HARRIER-SA™ Lumbar Interbody System
Choice Spine, LP 510(k) NO: K180519(Traditional)
ATTN: Kim Finch PHONE NO : 865 2433375
400 Erin Drive SE DECISION MADE: 16-MAY-18
Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEG-Now
EncephaloDynamics, Inc. 510(k) NO: K180524(Traditional)
ATTN: J. Chris Sackellares PHONE NO : 352 3279127
4320 NW 23rd Avenue, Suite 1 SE DECISION MADE: 18-MAY-18
Gainesville FL 32606 510(k) STATEMENT
DEVICE: IS3
Hiossen, Inc. 510(k) NO: K180527(Traditional)
ATTN: David Kim PHONE NO : 1 267 7597031
85 Ben Fairless Dr. SE DECISION MADE: 16-MAY-18
Fairless Hills PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
Samsung Electronics Co.,Ltd. 510(k) NO: K180543(Traditional)
ATTN: Jaesang Noh PHONE NO : 82 31 2001764
129, Samsung-Ro, Yeongtong-Gu SE DECISION MADE: 24-MAY-18
Suwon-Si KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUETTE SAFELINK Holder with male luer lock
Greiner Bio-One NA Inc. 510(k) NO: K180545(Traditional)
ATTN: Manfred Abel PHONE NO : 1 704 2617823
4238 Capital Drive SE DECISION MADE: 21-MAY-18
Monroe NC 28110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY Spore Test Strip for S40 Sterilant
Steris Corporation 510(k) NO: K180553(Traditional)
ATTN: Marcia L. Benedict PHONE NO : 440 3927695
5960 Heisley Road SE DECISION MADE: 29-MAY-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
Supersonic Imagine 510(k) NO: K180572(Traditional)
ATTN: Laurence Hermitte PHONE NO : 33 442 992424
Les Jardins de la Duranne - Bat E&SE DECISION MADE: 29-MAY-18
Aix-en-Provence FR 13857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sternal Cable System
A & E Medical Corporation 510(k) NO: K180582(Traditional)
ATTN: Hollie Johnson PHONE NO : 732 7387335
5206 Asbury Road SE DECISION MADE: 31-MAY-18
Farmingdale NJ 07727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Collagentex Rx-6
Tanses Technologies inc. 510(k) NO: K180585(Traditional)
ATTN: Kirk Kiremitci PHONE NO : 1 450 6224004
4450 Highway 13 SE DECISION MADE: 11-MAY-18
Fabreville CA H7R 6E9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venue
GE Medical Systems Ultrasound and 510(k) NO: K180599(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
LLC 9900 W. Innovation Drive SE DECISION MADE: 02-MAY-18
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMAVAC Device
SOMAVAC Medical Solutions, Inc. 510(k) NO: K180606(Traditional)
ATTN: Esra Roan PHONE NO : 901 6646370
20 South Dudley Street, Suite 100 SE DECISION MADE: 31-MAY-18
Memphis TN 38103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rodo Smilekey
Rodo Medical, Inc. 510(k) NO: K180609(Traditional)
ATTN: Michael Parsons PHONE NO : 408 2457636
6399 San Ignacio Ave., Suite 100 SE DECISION MADE: 23-MAY-18
San Jose CA 95119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ulthera System
Ulthera, Inc 510(k) NO: K180623(Traditional)
ATTN: Jessica Newhard PHONE NO : 480 6194069
1840 South Stapley Drive Suite 200SE DECISION MADE: 04-MAY-18
Mesa AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guided Growth Plate System Plus
Orthofix Srl 510(k) NO: K180624(Special)
ATTN: Gianluca Ricadona PHONE NO : 39 045 6719000
Via delle Nazioni 9 SE DECISION MADE: 15-MAY-18
Bussolengo IT 37012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rondek PGA Suture (Beige or Violet)
RK Manufacturing Corporation 510(k) NO: K180625(Traditional)
ATTN: Joshua Hubbard PHONE NO : 203 7978700
34 Executive Drive SE DECISION MADE: 10-MAY-18
Danbury CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invenia ABUS Viewer
GE Healthcare 510(k) NO: K180641(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
9900 Innovation Drive SE DECISION MADE: 04-MAY-18
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pro-Link® Ti Stand-Alone Cervical Spacer System
Life Spine Inc. 510(k) NO: K180642(Traditional)
ATTN: Randy Lewis PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 10-MAY-18
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex FastThread Interference Screw
Arthrex Inc. 510(k) NO: K180662(Special)
ATTN: Jessica L. Singelais PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard SE DECISION MADE: 22-MAY-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LaVid FMTS DIAGNOSTIC X-RAY SYSTEM
LIVERMORETECH Inc. 510(k) NO: K180663(Traditional)
ATTN: Jae Hong Kim PHONE NO : 1 214 2570113
801 North Jupiter Rd, Suite 200 SE DECISION MADE: 18-MAY-18
Plano TX 75074 510(k) STATEMENT
DEVICE: SeaSpine Daytona Small Stature Spinal System
SeaSpine Orthopedics Corporation 510(k) NO: K180686(Traditional)
ATTN: Gina Flores PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 14-MAY-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reliance Lumber IBF System
Reliance Medical Systems 510(k) NO: K180687(Special)
ATTN: Bret M Berry PHONE NO : 801 2953280
545 West 500 South Suite 100 SE DECISION MADE: 15-MAY-18
Bountiful UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KYPHON HV-R Bone Cement
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K180700(Traditional)
ATTN: Laveeda Leflore PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 18-MAY-18
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Endoscopic CO2 Regulator GW-100
FUJIFILM Corporation 510(k) NO: K180711(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 25-MAY-18
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LineUp
CurveBeam, LLC 510(k) NO: K180727(Third Party - Traditional)
ATTN: Stuti Singh PHONE NO : 267 4838081
175 Titus Ave Suite 300 SE DECISION MADE: 11-MAY-18
Warrington PA 18976 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VitriGuard
ORIGIO a/s 510(k) NO: K180740(Special)
ATTN: Roaida Johnson PHONE NO : 45 46790200
Knardrupvej 2 SE DECISION MADE: 04-MAY-18
Malov DK 2760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnsoETM
Advanced Cooling Therapy, Inc. d/b510(k) NO: K180742(Traditional)
ATTN: Erik Kulstad PHONE NO : 708 6510736
3440 S. Dearborn St. #215-South SE DECISION MADE: 17-MAY-18
Chicago IL 60616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Wire Guide Introducer
COOK Incorporated 510(k) NO: K180756(Traditional)
ATTN: Carly Powell PHONE NO : 812 3392235 104913
750 Daniels Way P.O. Box 489 SE DECISION MADE: 24-MAY-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acro HCG Pregnancy Rapid Test
ACRO Biotech, Inc. 510(k) NO: K180771(Traditional)
ATTN: Joseph Fan PHONE NO : 1 909 4666892
9500 Seventh Street, Suite M SE DECISION MADE: 18-MAY-18
Rancho Cucamonga CA 91730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reusable and Self-Adhesive Electrodes
Shaoxing DongZhi Electrical Techno510(k) NO: K180773(Traditional)
ATTN: Haze XU PHONE NO : 0086 0575 82597860
Xinsha Village, Cao E Street, ShanSE DECISION MADE: 22-MAY-18
Shaoxing CN 312352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cytal Wound Particulate
ACell, Inc. 510(k) NO: K180776(Special)
ATTN: Andrea Artman PHONE NO : 410 9538549
6640 Eli Whitney Drive Suite 200 SE DECISION MADE: 11-MAY-18
Columbia MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spineology Navigation Instruments
Spineology Inc. 510(k) NO: K180796(Special)
ATTN: Jacqueline A. Hauge PHONE NO : 651 2568500
7800 3rd Street N., Suite 600 SE DECISION MADE: 02-MAY-18
St. Paul MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clarius Ultrasound Scanner
Clarius Mobile Health Corp. 510(k) NO: K180799(Third Party - Traditional)
ATTN: Brendan Seward PHONE NO : 1 778 8009975
350 - 3605 Gilmore Way SE DECISION MADE: 14-MAY-18
Burnaby CA V5G 4X5 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Celling Aspiration Needle
SpineSmith Holdings, LLC 510(k) NO: K180807(Traditional)
ATTN: Clifton (Chris) Naivar PHONE NO : 512 6372068
4719 S Congress Ave SE DECISION MADE: 24-MAY-18
Austin TX 78745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omni Foot Plating System
Extremity Medical, LLC 510(k) NO: K180808(Traditional)
ATTN: Brian Smekal PHONE NO : 973 5888980
300 Interpace Parkway, Suite 410 SE DECISION MADE: 22-MAY-18
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biograph Vision
Siemens Medical Solutions USA, Inc510(k) NO: K180811(Traditional)
ATTN: Alaine Medio PHONE NO : 865 2182703
810 Innovation Drive SE DECISION MADE: 23-MAY-18
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AERIAL™ Interspinous Fixation
Globus Medical Inc. 510(k) NO: K180817(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 21-MAY-18
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
Menicon Co., Ltd. 510(k) NO: K180819(Traditional)
ATTN: Kenichi Tanaka PHONE NO : 81 52 9351676
21-19, Aoi 3, Naka-ku SE DECISION MADE: 16-MAY-18
Nagoya JP 460-0006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches
ArthroCare Corporation 510(k) NO: K180848(Special)
ATTN: Shruthi Bhat PHONE NO : 512 8951295
7000 West William Cannon Drive SE DECISION MADE: 01-MAY-18
Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System
Edan Instruments, Inc 510(k) NO: K180862(Traditional)
ATTN: Alice Yang PHONE NO : 86 755 26858736
#15 Jinhui Road,Jinsha Community KSE DECISION MADE: 24-MAY-18
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DTRAX Spinal System
Providence Medical Technology, Inc510(k) NO: K180876(Traditional)
ATTN: Edward Liou PHONE NO : 415 9239376
3857 Hopyard Rd. Suite 300 SE DECISION MADE: 18-MAY-18
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5D Viewer
Samsung Medison Co., Ltd. 510(k) NO: K180883(Third Party - Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 2 21941594
42, Teheran-ro 108-gil Gangnam-gu SE DECISION MADE: 15-MAY-18
Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
Liofilchem s. r. l. 510(k) NO: K180886(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 18-MAY-18
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: EVOL Spinal Interbody System, EVOS Lumbar Interbody System
Cutting Edge Spine, LLC 510(k) NO: K180891(Special)
ATTN: Kyle Kuntz PHONE NO : 704 2430892
101 Waxhaw Professional Park, SuitSE DECISION MADE: 04-MAY-18
Waxhaw NC 28173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Low Dose CT Lung Cancer Screening Option
Hitachi Healthcare Americas 510(k) NO: K180901(Traditional)
ATTN: Doug Thistlethwaite PHONE NO : 330 4251313
1959 Summit Commerce Park SE DECISION MADE: 16-MAY-18
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Conformis, Inc. 510(k) NO: K180906(Special)
ATTN: Emmanuel Nyakako PHONE NO : 781 3459001
600 Technology Park Drive, 4 FloorSE DECISION MADE: 16-MAY-18
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Irrigation Tubing Bipolar Cord Set
New Deantronics Taiwan Ltd 510(k) NO: K180908(Traditional)
ATTN: Jane Liu PHONE NO : 886 2 22681726
12F., No.51, Sec.4, Chong Yang Rd.SE DECISION MADE: 18-MAY-18
New Taipei City TW 23675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSI Micro-Introducer Kit
Vascular Solutions, Inc. 510(k) NO: K180913(Third Party - Traditional)
ATTN: Jake Schultz PHONE NO : 763 6564300
6464 Sycamore Court North SE DECISION MADE: 09-MAY-18
Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Empower H100, Cyber Ho 100, Litho 100
quanta system spa 510(k) NO: K180922(Special)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 376797
via Acquedotto 109 SE DECISION MADE: 08-MAY-18
Samarate (Va) IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klassic HD® Hip System
Total Joint Orthopedics, Inc. 510(k) NO: K180929(Special)
ATTN: Chris Weaber PHONE NO : 801 4866070
1567 E. Stratford Avenue SE DECISION MADE: 09-MAY-18
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diamond Orthopedic Bone Fixation Screws and Pins
Diamond Orthopedic, LLC 510(k) NO: K180932(Special)
ATTN: Roy Bivens PHONE NO : 704 5858258
1104 Spruce St SE DECISION MADE: 09-MAY-18
Belmont NC 28012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Graftgun Universal Graft Delivery System
Surgentec, LLC 510(k) NO: K180937(Special)
ATTN: Boca Raton PHONE NO : 561 9907882
7601 N Federal Hwy #150A SE DECISION MADE: 10-MAY-18
Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indigo Aspiration System - Modified 110 Aspiration Tubing
Penumbra, Inc. 510(k) NO: K180939(Special)
ATTN: Richard Kimura PHONE NO : 510 9952034
One Penumbra Place SE DECISION MADE: 03-MAY-18
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadiForce MX194
EIZO Corporation 510(k) NO: K180961(Abbreviated)
ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468
153 Shimokashiwano SE DECISION MADE: 10-MAY-18
Hakusan JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
Pixxgen Corporation 510(k) NO: K180976(Traditional)
ATTN: John Ross PHONE NO : 82 70 48468888
5F SMART BAY, 123, Beolmal-ro, DonSE DECISION MADE: 24-MAY-18
Anyang-si KR 14056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XableCath Support Catheter Product Family
XableCath, Inc. 510(k) NO: K180986(Special)
ATTN: Rick Gaykowski PHONE NO : 617 4474000
417 South Wakara Way, Suite 3510 SE DECISION MADE: 15-MAY-18
Salt Lake City UT 84108-1457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic Confida Brecker Guidewire
Medtronic Core Valve, LLC. 510(k) NO: K181001(Third Party - Traditional)
ATTN: Gerardine Drummond PHONE NO : 353 91 708914
Parkmore West SE DECISION MADE: 03-MAY-18
Galway IE 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VIVIX-S 1717V
Vieworks Co., Ltd. 510(k) NO: K181003(Traditional)
ATTN: Jordin Kim PHONE NO : 82 70 44961859
(Gwanyang-dong) 41-3, Burim-ro 170SE DECISION MADE: 15-MAY-18
Anyang-si KR 431-060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter
Meril Life Sciences Private Limite510(k) NO: K181023(Special)
ATTN: Utpal Thakor PHONE NO : 91 9601 260306
Bilakhia House, Survey No. 135/139SE DECISION MADE: 17-MAY-18
Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
DFI Co., Ltd. 510(k) NO: K181024(Traditional)
ATTN: Bella Cho PHONE NO : 82 55 3461882
388-25, Gomo-ro, Jillye-myeon, GimSE DECISION MADE: 23-MAY-18
Gyeongsangnam-do KR 621-881 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halcyon
Varian Medical Systems Inc. 510(k) NO: K181032(Special)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 09-MAY-18
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
Boston Scientific Corporation 510(k) NO: K181042(Special)
ATTN: Jennifer L. Foley PHONE NO : 952 9558049
3 Scimed Place SE DECISION MADE: 17-MAY-18
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: geko T-3 Neuromuscular Stimulator
Firstkind Limited 510(k) NO: K181059(Special)
ATTN: Neil Buckley PHONE NO : 44 0 1494572040
Hawk House, Peregrine Business ParSE DECISION MADE: 23-MAY-18
High Wycombe GB HP13 7DL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AlignX Ankle Fusion System
Extremity Medical, LLC 510(k) NO: K181067(Special)
ATTN: Brian Smekal PHONE NO : 973 5888980
300 Interpace Parkway, Suite 410 SE DECISION MADE: 23-MAY-18
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ActiGraph CentrePoint Insight Watch
ActiGraph 510(k) NO: K181077(Special)
ATTN: Brian Bell PHONE NO : 850 3327900
49 E Chase St SE DECISION MADE: 24-MAY-18
Pensacola FL 32502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: McKesson Cardiology
Change Healthcare Israel Ltd. 510(k) NO: K181080(Traditional)
ATTN: Nadia Marchant PHONE NO : 972 3 7698000
HaRokmim 26 SE DECISION MADE: 24-MAY-18
Holon IL 5885849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
Siemens Healthcare Diagnostics, In510(k) NO: K181082(Traditional)
ATTN: Kathleen Dray-Lyons PHONE NO : 617 6886117
500 GBC Drive SE DECISION MADE: 25-MAY-18
Newark NJ 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K181098(Third Party - Traditional)
ATTN: Christine Dunbar PHONE NO : 925 3742045
685 East Middlefield Road SE DECISION MADE: 31-MAY-18
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Fresenius Liberty Select Cycler
Fresenius Medical Care Renal Thera510(k) NO: K181108(Special)
ATTN: Denise Oppermann PHONE NO : 781 6994479
920 Winter Street SE DECISION MADE: 24-MAY-18
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navigated INFINITY Instruments
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K181111(Special)
ATTN: Tejas Patel PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 17-MAY-18
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOSAVE Intra-Aortic Balloon Pump
Datascope Corp. 510(k) NO: K181122(Special)
ATTN: Hemang Kotecha PHONE NO : 973 7097376
1300 MacArthur Blvd. SE DECISION MADE: 31-MAY-18
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tri-Ad 2.0 Adams Tricuspid Band
Medtronic 510(k) NO: K181132(Special)
ATTN: Tracy Gray PHONE NO : 949 3991678
1851 East Deere Ave SE DECISION MADE: 29-MAY-18
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CS 9600
Trophy 510(k) NO: K181136(Traditional)
ATTN: Marie-Pierre Labat-Camy PHONE NO : 33 1 64808500
4 Rue F. Pelloutier SE DECISION MADE: 24-MAY-18
Croissy Beaubourg FR 77435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eclipse Treatment Planning System
Varian Medical Systems, Inc. 510(k) NO: K181145(Special)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hensen Way SE DECISION MADE: 18-MAY-18
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProtekDuo Mini Veno-Venous Cannula Set
CardiacAssist Inc 510(k) NO: K181150(Special)
ATTN: Greg Johnson PHONE NO : 412 9637770
240 Alpha Drive SE DECISION MADE: 25-MAY-18
Pittsburg PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICEfx Cryoablation System
Galil Medical Inc. 510(k) NO: K181153(Special)
ATTN: Rachel Owens PHONE NO : 651 2875024
4364 Round Lake Road SE DECISION MADE: 15-MAY-18
Arden Hills MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Interventional Workspot
Philips Medical Systems Nederland 510(k) NO: K181177(Special)
ATTN: Chandrika Srinivasan PHONE NO : 91 974 0900311
Veenpluis 4-6 SE DECISION MADE: 31-MAY-18
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BrainScope One
BrainScope Company Inc. 510(k) NO: K181179(Special)
ATTN: Michael E Singer PHONE NO : 240 7527680
4350 East West Hwy, Ste 1050 SE DECISION MADE: 18-MAY-18
Bethesda MD 20814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVEREST Spinal System
K2M Inc. 510(k) NO: K181188(Special)
ATTN: Nancy Giezen PHONE NO : 571 9192000
600 Hope Pkwy. SE SE DECISION MADE: 30-MAY-18
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 252
TOTAL WITH SUMMARIES 236
TOTAL WITH STATEMENTS 16
