510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2019
DEVICE: Air Relax
Maxstar Industrial Co., Ltd 510(k) NO: K173158(Special)
ATTN: Lee BungHyun PHONE NO : 82 31 9893543
152 - 12 Hwanggeum-ro 23beon-gil, SE DECISION MADE: 30-MAY-19
Gimpo KR 415843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SD Abutment
Surgident Co., Ltd. 510(k) NO: K173570(Traditional)
ATTN: Ju Youn Choi PHONE NO : 82 31 7372875
#209-210, Woolim Lion's Valley, 27SE DECISION MADE: 17-MAY-19
Seongnam-si KR 13229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tel-O-Graph
I.E.M. Industrielle Entwicklung an510(k) NO: K173895(Traditional)
ATTN: Hella Witt PHONE NO : 49 2402 95000
Vertriebsgesellschaft mbH CockerilSE DECISION MADE: 16-MAY-19
Stolberg DE 52222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Manual Wheelchair W54
Jiangsu Jumao Medical Equipment Co510(k) NO: K180309(Traditional)
ATTN: Qian Gao PHONE NO : 86 511 86197066
No.36 Danyan road SE DECISION MADE: 03-MAY-19
Danyang City CN 212300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NS 120P-TRS Airway Pressure Gauge
Instrumentation Industries, Inc. 510(k) NO: K180510(Traditional)
ATTN: Doris Walter PHONE NO : 412 8541133
2990 Industrial Blvd. SE DECISION MADE: 01-MAY-19
Bethel Park PA 15102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clearlink System Solution Set
Baxter Healthcare Corporation 510(k) NO: K180739(Third Party - Traditional)
ATTN: Jeanette Licata PHONE NO : 224 9483996
32650 N. Wilson Road SE DECISION MADE: 28-MAY-19
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Conical Plus Implant System
OsseoFuse International, Inc. 510(k) NO: K181157(Traditional)
ATTN: Jennifer Cha PHONE NO : 888 4469995
5023 North Parkway Calabasas SE DECISION MADE: 24-MAY-19
Calabasas CA 91302 510(k) STATEMENT
DEVICE: FLIX-EMS
Casgarum Investment, S.L. 510(k) NO: K181419(Traditional)
ATTN: Rafael Castillo PHONE NO : 34 92 5512667
Calle Real, 17 Bº E SE DECISION MADE: 14-MAY-19
Illescas ES 45200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Delta Dual Mobility System
Limacorporate S.p.A. 510(k) NO: K181491(Traditional)
ATTN: Roberto Gabetta PHONE NO : 39 04 32945511
Via Nazionale 52 SE DECISION MADE: 09-MAY-19
Villanova di San Daniele IT 33038510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hysteroscope System
Shanghai AnQing Medical Instrument510(k) NO: K181545(Traditional)
ATTN: Lina FEI PHONE NO : 86 137 74253128
150 Cailun Road, Zhangjiang High-TSE DECISION MADE: 10-MAY-19
Shanghai CN 201210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revolution External Plating System
New Standard Device DBA Metalogix 510(k) NO: K181630(Traditional)
ATTN: Bryant Phamvu PHONE NO : 210 4921511
4766 Research Drive SE DECISION MADE: 29-MAY-19
San Antonio TX 78240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cocoon Convective Warming System
Care Essentials Pty Ltd 510(k) NO: K181671(Special)
ATTN: Abhay Sinha PHONE NO : 613 52771455
25 Slevin St SE DECISION MADE: 02-MAY-19
North Geelong AU 3215 510(k) STATEMENT
DEVICE: OssBuilder System
Osstem Implant Co., Ltd.. 510(k) NO: K181854(Traditional)
ATTN: Jungmin Yoo PHONE NO : 82 51 8502500
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 07-MAY-19
Busan KR 612-070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOF-Cuff monitor
RGB Medical Devices SA 510(k) NO: K181894(Abbreviated)
ATTN: Ricardo Ruiz PHONE NO : 34 91 3042011
Calle de Alfonso Gomez 42 SE DECISION MADE: 09-MAY-19
Madrid ES 28037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Sterilization Container System
Synthes (USA) Products LLC / DePuy510(k) NO: K181933(Traditional)
ATTN: Thomas Shea PHONE NO : 610 7195679
1301 Goshen Parkway SE DECISION MADE: 09-MAY-19
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
Teleflex Medical, Inc. 510(k) NO: K181979(Traditional)
ATTN: Sirisha Kommana PHONE NO : 919 4334831
3015 Carrington Mill Blvd, Suite 6SE DECISION MADE: 24-MAY-19
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: armor LC
Mavrik Dental Systems Ltd 510(k) NO: K182118(Traditional)
ATTN: Sherwyn Davidson PHONE NO : 972 9 9740100
25 Ha Haroshet Street, 6th floor SE DECISION MADE: 03-MAY-19
Raanana IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEAC System
Brain Sentinel, Inc. 510(k) NO: K182180(Traditional)
ATTN: Richard Waite PHONE NO : 214 6629277
8023 Vantage Dr., Suite 216 SE DECISION MADE: 11-MAY-19
San Antonio TX 78230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brush Biopsy Set ; Deflectable Brush Biopsy Set
Cook Incorporated 510(k) NO: K182231(Traditional)
ATTN: Thomas Palmer PHONE NO : 812 3392235 104964
750 Daniels Way SE DECISION MADE: 01-MAY-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OnSite Waste Sharps Container
Bluestone Medical, Inc. 510(k) NO: K182235(Traditional)
ATTN: Jon Bricken PHONE NO : 914 8863958
(DBA OnSite Waste Technologies, InSE DECISION MADE: 20-MAY-19
East Hampton NY 11937 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed ViewFlex Xtra ICE Catheter
Stryker Sustainability Solutions 510(k) NO: K182238(Traditional)
ATTN: Ramona Kulik PHONE NO : 480 7632952
1810 West Drake Drive SE DECISION MADE: 08-MAY-19
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION NitrX Medial-Pivot Knee
MircoPort Orthopedics, Inc. 510(k) NO: K182251(Traditional)
ATTN: Byron Ledbetter PHONE NO : 901 2905943
5677 Airline Road SE DECISION MADE: 16-MAY-19
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cook Unimpregnated Central Venous Catheter
Cook Incorporated 510(k) NO: K182252(Traditional)
ATTN: Johnathan Liu PHONE NO : 812 3353575 104509
750 Daniels Way SE DECISION MADE: 17-MAY-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CardioGard Emboli Protection Cannula
CardioGard Medical Ltd 510(k) NO: K182302(Traditional)
ATTN: Orit Ronan PHONE NO : 972 3 5467163
6 Yoni Netanyahu Street SE DECISION MADE: 17-MAY-19
Or-Yehuda IL 6037604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
Sri Trang Gloves (Thailand) Co., L510(k) NO: K182308(Abbreviated)
ATTN: Anan Pruksanusak PHONE NO : 66 74 344663
10 Soi 10 Phetkasem Road SE DECISION MADE: 30-MAY-19
Hatyai TH 90110 510(k) STATEMENT
DEVICE: MobileLink Acetabular Cup System
Waldemar Link GmbH & Co. KG 510(k) NO: K182321(Traditional)
ATTN: Karen Sonnenberger PHONE NO : 49 40 53995517
Oststrabe 4-10 SE DECISION MADE: 24-MAY-19
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VeriClear Digital Early Result Pregnancy Test
True Diagnostics, Inc. 510(k) NO: K182328(Traditional)
ATTN: Jerry Lee PHONE NO : 888 5718597 700
2782 Loker Ave West SE DECISION MADE: 15-MAY-19
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntraLock Lapidus System
Fusion Orthopedics, LLC 510(k) NO: K182342(Traditional)
ATTN: Eli Jacobson PHONE NO : 800 4036876
4135 S. Power Rd., Suite 110 SE DECISION MADE: 21-MAY-19
Mesa AZ 85212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Ceramic
Baot Biological Technology Co., LT510(k) NO: K182350(Traditional)
ATTN: Liqun Zhu PHONE NO : 86 760 87893826
Unit 1, Second Floor, No 12 BuildiSE DECISION MADE: 22-MAY-19
Zhongshan CN 528437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MaxCap Ped and MaxCap Neo
Maxtec, LLC 510(k) NO: K182362(Traditional)
ATTN: Tammy Lavery PHONE NO : 385 5498049
2305 S 1070 W SE DECISION MADE: 23-MAY-19
Salt Lake City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAC S
Sit Sordina Iort Technologies Spa 510(k) NO: K182374(Traditional)
ATTN: Alessia Giaffreda PHONE NO : 39 0444 233711
Galleria Del Rosso Pozzo 13 SE DECISION MADE: 22-MAY-19
Vicenza IT 36100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPEDE-FX Embolization Plug
Shape Memory Medical 510(k) NO: K182390(Traditional)
ATTN: Meghan Reu PHONE NO : 408 6495175 711
807 Aldo Avenue, Suite 109 SE DECISION MADE: 23-MAY-19
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WiZARD 310/320 Series CPAP Mask
Apex Medical Corp. 510(k) NO: K182394(Traditional)
ATTN: Frank Lin PHONE NO : 886 2 22685568
No. 9 Min Sheng St. Tu-Cheng SE DECISION MADE: 17-MAY-19
New Taipei City TW 23679 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peel-Away Introducer
Cook Incorporated 510(k) NO: K182403(Traditional)
ATTN: Johnathan Liu PHONE NO : 812 3352235 104509
750 Daniels Way SE DECISION MADE: 29-MAY-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
Olympus Medical Systems Corp. 510(k) NO: K182408(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 15-MAY-19
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlucoLeader Enhance Blood Glucose Monitoring System
HMD BioMedical Inc. 510(k) NO: K182428(Traditional)
ATTN: Jen Ke-Min PHONE NO : 88 63 5895000
No. 181 Minsheng St., Xinpu TownshSE DECISION MADE: 08-MAY-19
Hsin Chu County TW 30542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARFIL MAJESTY IC
Kuraray Noritake Dental Inc. 510(k) NO: K182430(Traditional)
ATTN: Yasujiro Ohara PHONE NO : 81 3 67011706
Ote Center Bldg. 7F, 1-1-3, OtemacSE DECISION MADE: 03-MAY-19
Chiyoda-ku JP 100-0004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless Intelligent Thermometer
Shenzhen Jumper Medical Equipment 510(k) NO: K182437(Traditional)
ATTN: Tom Tom PHONE NO : 86 755 26696279
D Building, No. 71, Xintian Road, SE DECISION MADE: 05-MAY-19
Shenzhen CN 518100 510(k) STATEMENT
DEVICE: Pristine Hemodialysis Catheter
Pristine Access Technologies Ltd. 510(k) NO: K182443(Traditional)
ATTN: Ron Livne PHONE NO : 972 775055645
21 (B) Habarzel Street SE DECISION MADE: 31-MAY-19
Tel Aviv IL 6971029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Longterm NPWT Foam Dressing Kit
Zhejiang Longterm Medical Technolo510(k) NO: K182458(Traditional)
ATTN: Claudia Zsang PHONE NO : 1 416 2769555
No. 493 North Huancheng Road MoganSE DECISION MADE: 23-MAY-19
Deqing CN 313200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MD-6000P Bladder Scanner
Meda Co., LTD 510(k) NO: K182460(Traditional)
ATTN: Linda Zhang PHONE NO : 86 22 83713808
F2C,F3D,F4C,F5, F6C, Bldg C2, XinmSE DECISION MADE: 06-MAY-19
Tianjin CN 300384 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
BioSystems S.A. 510(k) NO: K182474(Traditional)
ATTN: Noelia Gil PHONE NO : 34 933 110000 4108
Costa Brava, 30 SE DECISION MADE: 02-MAY-19
Barcelona ES 08030 510(k) STATEMENT
DEVICE: Surgical Face Mask
Wuhan Dymex Healthcare Co., Ltd 510(k) NO: K182515(Traditional)
ATTN: Ada Liu PHONE NO : 86 278462 18988003
Room 1701, Unit 2, Building 5, JinSE DECISION MADE: 27-MAY-19
Wuhan CN 430000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Overtube
Sumitomo Bakelite Co., Ltd 510(k) NO: K182520(Traditional)
ATTN: Shiro Agehama PHONE NO : 81 354 624811
5-8, Higashi-Shinagawa 2-chome SE DECISION MADE: 15-MAY-19
Shinagawa-ku JP 1400002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)
Vcomin Technology Limited 510(k) NO: K182526(Traditional)
ATTN: Han JieLin PHONE NO : 86 755 33826016
2&3 FI., No. 1, Kangzheng Rd., BujSE DECISION MADE: 29-MAY-19
Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liba3 System
National Cardiac, Inc. 510(k) NO: K182532(Traditional)
ATTN: Scott Mallett PHONE NO : 800 5514354
221 W. Crest Street Suite 205 SE DECISION MADE: 15-MAY-19
Escondido CA 92025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccelFix Spinal Fixation System
L&K BioMed Co., Ltd. 510(k) NO: K182544(Traditional)
ATTN: Jihyeon Seo PHONE NO : 82 2 67171983
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 28-MAY-19
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Jiangxi Jaysun Medicare Co., Ltd. 510(k) NO: K182575(Traditional)
ATTN: Zong Run PHONE NO :
No.1 Jaysun Road, Penghuwan IndustSE DECISION MADE: 24-MAY-19
Jiujiang CN 332708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solax Powered Wheelchair
Dongguan Prestige Sporting Goods C510(k) NO: K182576(Traditional)
ATTN: Zhang Zhao PHONE NO : 86 137 63128800
3rd Ind. District, Qiaotou Area, HSE DECISION MADE: 21-MAY-19
Dongguan CN 523950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFIA EX Intracranial Support Catheter
Micro Vention Inc. 510(k) NO: K182602(Traditional)
ATTN: Tina Ariaee PHONE NO : 714 2478000 8366
35 Enterprise SE DECISION MADE: 15-MAY-19
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Qangio XA 3D
Medis Medical Imaging Systems bv 510(k) NO: K182611(Traditional)
ATTN: B. Goedhart PHONE NO : 31 71 5241700
Schuttersveld 9 SE DECISION MADE: 30-MAY-19
Leiden NL 2316 xG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)
Zibo Yahao Supplies Co., LTD 510(k) NO: K182612(Traditional)
ATTN: Fiona Xin PHONE NO : 86 533 7871082
The 6th floor, NO.8, Niushan Road,SE DECISION MADE: 10-MAY-19
Zibo CN 255414 510(k) STATEMENT
DEVICE: ATEC IOM Accessory Instruments
Alphatec Spine, Inc 510(k) NO: K182617(Traditional)
ATTN: Jeremy Markovich PHONE NO : 760 4946893
5818 El Camino Real SE DECISION MADE: 09-MAY-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitreq disposable laser probes, light fibers and Chandelier
Vitreq B.V. 510(k) NO: K182646(Traditional)
ATTN: JanKees Wouts PHONE NO : 31 181 745090
Segglant-Noord 2 SE DECISION MADE: 01-MAY-19
Vierpolders NL 3237MG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GaltTWS
Galt Medical Corp. 510(k) NO: K182660(Traditional)
ATTN: David Derrick PHONE NO : 972 2715177
2220 Merritt Drive SE DECISION MADE: 30-MAY-19
Garland TX 75087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
Zimmer, Inc 510(k) NO: K182678(Traditional)
ATTN: Caleb Barylski PHONE NO : 574 3710250
PO Box 708 SE DECISION MADE: 31-MAY-19
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
Kelyniam Global Inc. 510(k) NO: K182711(Traditional)
ATTN: Eric Boyea PHONE NO : 800 2808192
97 River Road, Suite A SE DECISION MADE: 21-MAY-19
Canton CT 06019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brain Perfusion (BP) application
Philips Medical Systems Nederland 510(k) NO: K182716(Traditional)
ATTN: Yoram Levy PHONE NO : 1 800 7229377
Veenpluis 4-6 SE DECISION MADE: 29-MAY-19
Best Noord-Brabant NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apis
SweetBio, Inc 510(k) NO: K182725(Traditional)
ATTN: Kayla Graff PHONE NO : 415 3611649
20 Dudley Street, Suite 900 SE DECISION MADE: 31-MAY-19
Memphis TN 38103-4904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
UNICON Optical CO., LTD 510(k) NO: K182734(Traditional)
ATTN: HSIAO-WEI SHEN PHONE NO : 886 3 5775586
No 16, Gongye E. 9th Rd. Hsinchu SSE DECISION MADE: 16-MAY-19
Hsinchu County TW 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Instruments Kits
JJGC Industria e Comercio de Mater510(k) NO: K182865(Traditional)
ATTN: Julianne de Oliveira CapuchoPHONE NO : 55 41 21694058
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 07-MAY-19
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALF DOME Posterior Lumbar Interbody System
Astura Medical, LLC 510(k) NO: K182877(Traditional)
ATTN: Parker Kelch PHONE NO : 760 8148047
3186 Lionshead Ave, Suite 100 SE DECISION MADE: 03-MAY-19
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Segmented Esophageal Stent System
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K182910(Traditional)
ATTN: Becky Li PHONE NO : 86 25 58646378
No. 10 Gaoke Third Road SE DECISION MADE: 29-MAY-19
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Upstream GoBack Crossing Catheter
Upstream Peripheral Technologies, 510(k) NO: K182937(Traditional)
ATTN: Dan Rottenberg PHONE NO : 972 4 6239014
ARAN Building, P.O. Box 3067; 43 HSE DECISION MADE: 23-MAY-19
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wallace Dual Lumen Oocyte Recovery System
CooperSurgical Inc. 510(k) NO: K182959(Traditional)
ATTN: Roaida Johnson PHONE NO : 203 6015200 3325
95 Corporate Drive SE DECISION MADE: 10-MAY-19
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAKO 7
Boston Scientific Corporation 510(k) NO: K182975(Traditional)
ATTN: Ibhina Sherchan PHONE NO : 508 6834215
100 Boston Scientific Way SE DECISION MADE: 21-MAY-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SteriCap Mini Needle
OcuJet, LLC 510(k) NO: K183016(Special)
ATTN: Rebecca K Pine PHONE NO : 760 8095178
1441 Avocado Ave, Suite 204 SE DECISION MADE: 07-MAY-19
Newport Beach CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle
Cook Incorporated 510(k) NO: K183035(Traditional)
ATTN: Yan Li PHONE NO : 812 3352235 104987
750 Daniels Way SE DECISION MADE: 17-MAY-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNMESH System
DePuy Synthes Spine 510(k) NO: K183054(Traditional)
ATTN: Michelle Hughes PHONE NO : 904 6081262
325 Paramount Drive SE DECISION MADE: 23-MAY-19
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Delta Xtend Reverse Shoulder System
DePuy (Ireland) 510(k) NO: K183077(Traditional)
ATTN: Yayoi Fujimaki PHONE NO : 508 8283541
Loughbeg Ringaskiddy SE DECISION MADE: 17-MAY-19
Co. Cork Munster IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fuji Cervical Plate System
Altus Partners, LLC 510(k) NO: K183084(Special)
ATTN: Mark Melton PHONE NO : 610 3554156
1340 Enterprise Drive SE DECISION MADE: 29-MAY-19
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ControlRad Trace Model 8
ControlRad, Inc. 510(k) NO: K183109(Traditional)
ATTN: Guillaume Bailliard PHONE NO : 1 610 9772422
150 N. Radnor Chester Road, Suite SE DECISION MADE: 13-MAY-19
Radnor PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrosurgical accessory
New Deantronics Taiwan Ltd 510(k) NO: K183126(Traditional)
ATTN: Jane Liu PHONE NO : 886 2 22681726
SE DECISION MADE: 08-MAY-19
New Taipei City TW 23675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
Haemonetics Corporation 510(k) NO: K183160(Traditional)
ATTN: Nancy Bengtson PHONE NO : 847 6531407
400 Wood Road SE DECISION MADE: 09-MAY-19
Braintree MA 02184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
Richard Wolf Medical Instruments C510(k) NO: K183188(Traditional)
ATTN: Mike Loiterman PHONE NO : 847 9131113
353 Corporate Woods Parkway SE DECISION MADE: 03-MAY-19
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIO Handpiece
OmniGuide, Inc. 510(k) NO: K183199(Traditional)
ATTN: Samuel Wade PHONE NO : 617 5518410
4 Maguire Road SE DECISION MADE: 02-MAY-19
Lexington MA 02412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
EmCyte Corporation 510(k) NO: K183205(Special)
ATTN: Patrick Pennie PHONE NO : 239 4817725
4331 Veronica S. Shoemaker Blvd, SSE DECISION MADE: 30-MAY-19
Fort Myers FL 33916 510(k) STATEMENT
DEVICE: ET IV SA Dental Implants
Hiossen, Inc. 510(k) NO: K183242(Special)
ATTN: Peter Lee PHONE NO : 888 6780001
85 Ben Fairless Drive SE DECISION MADE: 21-MAY-19
Fairless Hills PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpO2 Sensor
Shenzhen Upnmed Equipment Co., Ltd510(k) NO: K183277(Traditional)
ATTN: Fu Jian PHONE NO : 86 755 29728789
4th Floor, Building #1 East, HuijuSE DECISION MADE: 15-MAY-19
Shenzhen CN 518107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Topaz Mobile DR System
DRGEM Corporation 510(k) NO: K183292(Traditional)
ATTN: Ki-Nam Yang PHONE NO : 82 2 8698566
7F E-B/D Gwangmyeong Techno-Park 6SE DECISION MADE: 15-MAY-19
Gwangmyeong-si KR 14322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Encore System
Siesta Medical, Inc 510(k) NO: K183310(Traditional)
ATTN: Michael Kolber PHONE NO : 408 5056626
101 Church Street, Suite 3 SE DECISION MADE: 09-MAY-19
Los Gatos CA 95030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triangle System
AliveCor, Inc. 510(k) NO: K183319(Traditional)
ATTN: Prabhu Raghavan PHONE NO : 650 3968553
444 Castro Street, Suite 600 SE DECISION MADE: 10-MAY-19
Mountain View CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Entuit PEG, Entuit PEGJ
Wilson-Cook Medical, Inc 510(k) NO: K183336(Traditional)
ATTN: Tiffany A. Thomas PHONE NO : 336 7440157 396680
4900 Bethania Station Road SE DECISION MADE: 29-MAY-19
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2
DMG Chemisch-Pharmazeutische Fabri510(k) NO: K183337(Traditional)
ATTN: Sonja Toeppen PHONE NO : 49 040 840060
Elbgaustrasse 248 SE DECISION MADE: 29-MAY-19
Hamburg DE 22547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navigation Enabled Instruments
STRYKER 510(k) NO: K183381(Traditional)
ATTN: Megan Callanan PHONE NO : 201 7498000
2 Pearl Court SE DECISION MADE: 17-MAY-19
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
GE Healthcare Finland Oy 510(k) NO: K183394(Special)
ATTN: Joel Kent PHONE NO : 358 10 39411
Kuortaneenkatu 2 SE DECISION MADE: 01-MAY-19
Helsinki FI FI-00510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruWave Disposable Pressure Transducer
Edwards Lifeciences, LLC 510(k) NO: K183413(Traditional)
ATTN: Ye Seul Kim PHONE NO : 949 2502445
One Edwards Way SE DECISION MADE: 01-MAY-19
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iRestore Professional 282
Freedom Laser Therapy, Inc. 510(k) NO: K183417(Traditional)
ATTN: Craig Nabat PHONE NO : 714 6699888
16782 Von Karman Avenue, Unit #15 SE DECISION MADE: 17-MAY-19
Irvine CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas u 601 urinalysis test system
Roche Diagnostics 510(k) NO: K183432(Traditional)
ATTN: Angela Clements PHONE NO : 317 5217338
9115 Hague Road SE DECISION MADE: 07-MAY-19
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SomnoDent Avant
SomnoMed Inc. 510(k) NO: K183443(Abbreviated)
ATTN: Dorene Markwiese PHONE NO : 1 888 4476673
6513 Windcrest Drive SE DECISION MADE: 08-MAY-19
Plano TX 75024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
Teleflex Medical, Inc 510(k) NO: K183461(Traditional)
ATTN: Lori Pfohl PHONE NO : 919 4918960
3015 Carrington Mill Blvd , Suite SE DECISION MADE: 08-MAY-19
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KY Banksy Moisture
RB Health (US) LLC 510(k) NO: K183505(Traditional)
ATTN: Elizabeth Viguerie PHONE NO : 973 4042600
399 Interpace Parkway SE DECISION MADE: 17-MAY-19
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Moore Park Mask
ResMed Ltd 510(k) NO: K183512(Traditional)
ATTN: Nerida Hunt PHONE NO : 612 8884 1000
1 Elizabeth Macarthur Drive SE DECISION MADE: 07-MAY-19
Bella Vista AU 2153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR8 Drill System, Midas Rex MR8 ClearView Tools
Medtronic Powered Surgical Solutio510(k) NO: K183515(Traditional)
ATTN: Jenna Groves PHONE NO : 817 7886686___
4620 North Beach Street SE DECISION MADE: 12-MAY-19
Fort Worth TX 76137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruDiagnosis System
Akonni Biosystems Inc. 510(k) NO: K183530(Traditional)
ATTN: Charles Daitch PHONE NO : 301 6980101
400 Sagner Ave, Suite 300 SE DECISION MADE: 24-MAY-19
Frederick MD 21701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co., Ltd. 510(k) NO: K183534(Abbreviated)
ATTN: Liu Yi PHONE NO : 86 22 87611660 9060
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 16-MAY-19
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luna 3D GEN2 Interbody Fusion System
Benvenue Medical, Inc. 510(k) NO: K183560(Traditional)
ATTN: Laurent Schaller PHONE NO : 408 4549300
4590 Patrick Henry Dr. SE DECISION MADE: 23-MAY-19
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Quick-Clear Wand
Medline Industries, Inc. 510(k) NO: K183577(Traditional)
ATTN: Dinah Rincones PHONE NO : 847 9792687
Three Lakes Drive SE DECISION MADE: 04-MAY-19
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vanguard Complete Knee System
Zimmer Inc. 510(k) NO: K183583(Traditional)
ATTN: Charles Neitzel PHONE NO : 262 7163243
P.O. Box 708 SE DECISION MADE: 10-MAY-19
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QIAstat-Dx Respiratory Panel
QIAGEN GmbH 510(k) NO: K183597(Traditional)
ATTN: Lindsey Howard PHONE NO : 1 240 6867826
Qiagen Strasse 1 SE DECISION MADE: 18-MAY-19
Hilden DE 40724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Soniquence RF Generator and Soniquence Electrodes
Soniquence, LLC 510(k) NO: K183611(Traditional)
ATTN: Suzanne Lucas PHONE NO : 516 6548017
2473 Grand Avenue SE DECISION MADE: 22-MAY-19
Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revolution Radial Head
Ignite Orthopedics, Inc. 510(k) NO: K183618(Traditional)
ATTN: Russ Parrott PHONE NO : 574 5272864
210 North Buffalo Street SE DECISION MADE: 17-MAY-19
Warsaw, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mariner Outrigger Revision System
SeaSpine Orthopedics Corporation 510(k) NO: K183639(Traditional)
ATTN: Gina Flores PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 23-MAY-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stealth-Midas MR8 System
Medtronic Powered Surgical Solutio510(k) NO: K183644(Traditional)
ATTN: Jenna Groves PHONE NO : 817 7886686
4620 North Beach Street SE DECISION MADE: 22-MAY-19
Fox Worth TX 76137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silver High Performance Dressing
Advanced Medical Solutions Ltd. 510(k) NO: K183645(Traditional)
ATTN: Amy Turner PHONE NO : 44 1606 863500
Premier Park, 33 , Winsford IndustSE DECISION MADE: 29-MAY-19
Winsford GB CW7 3RT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure
Edwards Lifeciences, LLC 510(k) NO: K183646(Traditional)
ATTN: Lisa Gilman PHONE NO : 949 2501478
One Edwards Way SE DECISION MADE: 21-MAY-19
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APAS Independence with Urine Analysis Module
Clever Culture Systems AG 510(k) NO: K183648(Traditional)
ATTN: Julie Winson PHONE NO : 61 2 99062984
Seestrasse 204a SE DECISION MADE: 15-MAY-19
Bach CH CH-8806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
PENTAX of America, Inc. 510(k) NO: K183654(Special)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 23-MAY-19
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaCross Transseptal Sheath
Baylis Medical Company Inc. 510(k) NO: K183655(Traditional)
ATTN: Meghal Khakhar PHONE NO : 1 905 6024875 252
2645 Matheson Blvd. East SE DECISION MADE: 20-MAY-19
Mississauga CA L4W 4J1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Rad-97 and Accessories
Masimo Corporation 510(k) NO: K183697(Traditional)
ATTN: Sindura Penubarthi PHONE NO : 949 2977592
52 Discovery SE DECISION MADE: 15-MAY-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker ChestShield Sterilization Tray System
Paragon Medical 510(k) NO: K183701(Traditional)
ATTN: Rebecca Walker PHONE NO : 574 5942140
8 Matchett Dr. SE DECISION MADE: 07-MAY-19
Pierceton IN 46562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
Ansell Healthcare Products, LLC. 510(k) NO: K190018(Traditional)
ATTN: Don Cronk PHONE NO : 775 4707106
2301 Robb Drive SE DECISION MADE: 23-MAY-19
Reno NV 89523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SteriStay
Toul Meditech AB 510(k) NO: K190027(Traditional)
ATTN: Tomas Hansson PHONE NO : 46 21 135000
Tunbytorpsgatan 31 SE DECISION MADE: 10-MAY-19
Vasteras SE 72137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMY Medical Therapy Laser System
Footdocprenur, LLC 510(k) NO: K190034(Traditional)
ATTN: David Zuckerman PHONE NO : 1 856 2292939
1803 Country Club Drive SE DECISION MADE: 15-MAY-19
Cherry Hill NJ 08003 510(k) STATEMENT
DEVICE: Arrowhead Hexapod Fixator
Arrowhead DE, LLC 510(k) NO: K190069(Traditional)
ATTN: Thomas J. Twardzik PHONE NO : 901 8534366
328 Poplar View Lane East, Suite 2SE DECISION MADE: 14-MAY-19
Collierville TN 38017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove
Molnlycke Health Care, US LLC 510(k) NO: K190077(Traditional)
ATTN: Leonard Stewart PHONE NO : 470 3750178
5550 Peachtree Parkway, Suite 500 SE DECISION MADE: 24-MAY-19
Norcross GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leaf Photocoagulator
Norlase ApS 510(k) NO: K190083(Traditional)
ATTN: Jan Forstberg PHONE NO : 011 4540 109302
Brydehusvej 302750 SE DECISION MADE: 03-MAY-19
Ballerup DK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNiD Patient specific 3D printed TLIF cage
Medicrea International S.A. 510(k) NO: K190092(Traditional)
ATTN: David Ryan PHONE NO : 0033 4 72018787
5389 route de Strasbourg SE DECISION MADE: 08-MAY-19
Rillieux-La-Pape FR 69140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
T.A.G. Medical Products Corporatio510(k) NO: K190125(Traditional)
ATTN: Shlomi Dines PHONE NO : 972 4 9858400
Gaaton SE DECISION MADE: 19-MAY-19
Gaaton IL 2513000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Full Automatic (NIBP) Blood Pressure Monitor-HL158TB
Health & Life Co., Ltd. 510(k) NO: K190134(Special)
ATTN: JS Hsu PHONE NO : 886 2 82271300 1201
9F, No. 186, Jian Yi Road SE DECISION MADE: 20-MAY-19
Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLOSSEUM Mesh
Globus Medical Inc. 510(k) NO: K190147(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 08-MAY-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
bioMerieux SA 510(k) NO: K190154(Traditional)
ATTN: Marine Taravant PHONE NO : 33 04 78872126
376, chemin de l'Orme SE DECISION MADE: 01-MAY-19
Marcy-l'Etoile FR 69280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
Showa Best Glove, Inc. 510(k) NO: K190159(Traditional)
ATTN: Jefferey Richardson PHONE NO : 706 8626000
579 Edison Street SE DECISION MADE: 06-MAY-19
Menlo GA 30731-6355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: neXus Ultrasonic Surgical Aspirator System
Misonix, Inc. 510(k) NO: K190160(Traditional)
ATTN: John Salerno PHONE NO : 631 9279123
1938 New Highway SE DECISION MADE: 30-MAY-19
Farmingdale NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray
Gebauer Company 510(k) NO: K190161(Traditional)
ATTN: Brittney Cooper PHONE NO : 216 5813030
4444 East 153rd Street SE DECISION MADE: 07-MAY-19
Cleveland OH 44128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capstone Control™ Spinal System
Medtronic Sofamor Danek USA, INC. 510(k) NO: K190165(Traditional)
ATTN: Justin O'Connor PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 06-MAY-19
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MitraClip G4 Steerable Guide Catheter
Abbott 510(k) NO: K190167(Special)
ATTN: Ekta Lad PHONE NO : 408 8450937
3200 Lakeside Drive SE DECISION MADE: 29-MAY-19
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MVP Cervical Plate System
GS Medical Co., Ltd. 510(k) NO: K190170(Traditional)
ATTN: Barry Sands PHONE NO : 352 3274641
90, Osongsaengmyeong 4-Ro SE DECISION MADE: 13-MAY-19
Osong-Eup KR 363-951 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
JK-Holding GmbH 510(k) NO: K190173(Traditional)
ATTN: Juergen Gerstenmeier PHONE NO : 49 2224 818330
Koehlershohner Strabe 60 SE DECISION MADE: 10-MAY-19
Windhagen DE 53578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unity Subcutaneous Delivery System for Remodulin
DEKA Research & Development 510(k) NO: K190182(Traditional)
ATTN: Brian Carney PHONE NO : 603 6695139
340 Commercial Street SE DECISION MADE: 06-MAY-19
Manchester NH 03101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gynescope System
Illumigyn Ltd. 510(k) NO: K190187(Traditional)
ATTN: Lior Greenstein PHONE NO : 972 2 5476319
Communication Center SE DECISION MADE: 08-MAY-19
Neve Ilan IL 9085000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
PENTAX Medical, A Division of PENT510(k) NO: K190194(Traditional)
ATTN: Gurvinder Singh Nanda PHONE NO : 650 3168601
303 Convention Way, Suite 1 SE DECISION MADE: 31-MAY-19
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unscented Menstrual Tampon
Qingdao Youjia Hygiene Technology 510(k) NO: K190218(Traditional)
ATTN: Huiying Zhao PHONE NO : 86 532 86613616
No. 778 Mingyue Road, Huangdao ZonSE DECISION MADE: 09-MAY-19
Qingdao CN 266400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simplexa VZV Direct, Simplexa VZV Positive Control Pack
DiaSorin Molecular LLC 510(k) NO: K190219(Traditional)
ATTN: Sharon Young PHONE NO : 562 2406500
11331 Valley View Street SE DECISION MADE: 13-MAY-19
Cypress CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FilmArray Pneumonia/Pneumoniaplus Control
Maine Molecular Quality Controls, 510(k) NO: K190222(Traditional)
ATTN: Joan Gordon PHONE NO : 207 8851072
23 Mill Brook Road SE DECISION MADE: 03-MAY-19
Saco ME 04072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cepheid Xpert CT/NG Control Panel
Microbiologics, Inc. 510(k) NO: K190223(Traditional)
ATTN: Tina Sobania PHONE NO : 320 2297050
200 Cooper Avenue North SE DECISION MADE: 08-MAY-19
St. Cloud MN 56303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Boomerang™ Anterior Cervical Plate System
ChoiceSpine, LP 510(k) NO: K190227(Traditional)
ATTN: Kim Finch PHONE NO : 865 2433375
400 Erin Drive SE DECISION MADE: 01-MAY-19
Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InCore® Lapidus Sterile Kits
Nextremity Solutions, Inc. 510(k) NO: K190231(Traditional)
ATTN: Greg Denham PHONE NO : 732 3837901
210 North Buffalo Street SE DECISION MADE: 24-MAY-19
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-Shield Advantage Port Access Infusion Set (PAIS)
Kawasumi Laboratories, Inc. 510(k) NO: K190233(Special)
ATTN: Katsu Furuya PHONE NO : 81 3 57692664
Shinagawa Intercity Tower B, 9th FSE DECISION MADE: 02-MAY-19
Tokyo JP 108-6109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tiger Sharps Containers
International Marketing Specialist510(k) NO: K190240(Traditional)
ATTN: Rod Calderon PHONE NO : 606 6772616
1278 HWY 461 SE DECISION MADE: 31-MAY-19
Somerset KY 42503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroShield
Monarch Bioimplants GmbH 510(k) NO: K190246(Traditional)
ATTN: Rivelino Montenegro PHONE NO : 41 41 4552261
Platz 4 SE DECISION MADE: 31-MAY-19
Root CH 6039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeoLSD MSMS Kit
PerkinElmer Inc. 510(k) NO: K190266(Traditional)
ATTN: Brian Ciccariello PHONE NO : 781 6635651
940 Winter Street SE DECISION MADE: 03-MAY-19
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GenePOC Carba
GenePOC Inc. 510(k) NO: K190275(Traditional)
ATTN: Dany Leblanc PHONE NO : 1 418 6503535
360 rue Franquet SE DECISION MADE: 10-MAY-19
Quebec CA G1P 4N3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AuraGen 123 Suction Lipoplasty System (A123)
AuraGen Aesthetics LLC 510(k) NO: K190278(Traditional)
ATTN: Yiannis Monovoukas PHONE NO : 617 8184008
11 Dellbrook Road SE DECISION MADE: 03-MAY-19
Weston MA 02493 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
Spectrum Medical Ltd 510(k) NO: K190282(Traditional)
ATTN: Colleen Powell PHONE NO : 440 1242 387082
Harrier 4, Meteor Business Park, CSE DECISION MADE: 24-MAY-19
Gloucester GB GL2 9QL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex DynaNite® PIP (Hammertoe) Implant
Arthrex Inc. 510(k) NO: K190287(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 03-MAY-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celerity HP Incubator
Steris Corporation 510(k) NO: K190297(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 14-MAY-19
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U Deliver Bolink ENFit Enteral Feeding Sets
U Deliver Medical, LLC 510(k) NO: K190310(Traditional)
ATTN: Brian Johnson PHONE NO : 952 2000720
7900 Excelsior Blvd Suite 108 SE DECISION MADE: 31-MAY-19
Hopkins MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat
Phadia AB 510(k) NO: K190315(Traditional)
ATTN: Ulf Karlberg PHONE NO : 46 18 165000
Rapsgatan 7P SE DECISION MADE: 14-MAY-19
Uppsala SE 75137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aperio AT2 DX System
Leica Biosystems Imaging, Inc. 510(k) NO: K190332(Traditional)
ATTN: Christine Kishi PHONE NO : 760 5391194
1360 Park Center Dr. SE DECISION MADE: 20-MAY-19
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VPC
Pajunk GmbH Medizintechnologie 510(k) NO: K190345(Traditional)
ATTN: Christian G.H Quass PHONE NO : 49 770 49219586
Karl-Hall-Str. 1 SE DECISION MADE: 16-MAY-19
Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precision Casting Solutions Total Knee System
Precision Casting Solutions, Inc. 510(k) NO: K190355(Traditional)
ATTN: Jim Moore PHONE NO : 503 4211251
20031 Henrici Road SE DECISION MADE: 16-MAY-19
Oregon City OR 97045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HealthPNX
Zebra Medical Vision Ltd. 510(k) NO: K190362(Traditional)
ATTN: Flair Bar PHONE NO : 972 9 8827795
Shefayim Commercial Center, PO BoxSE DECISION MADE: 06-MAY-19
Shefayim IL 6099000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith & Nephew Tablet Application
Smith & Nephew 510(k) NO: K190367(Traditional)
ATTN: Janice Haselton PHONE NO : 978 7491494
150 Minuteman Road SE DECISION MADE: 21-MAY-19
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aveta System
Meditrina, Inc. 510(k) NO: K190372(Traditional)
ATTN: Csaba Truckai PHONE NO : 408 4714877
1601 S. De Anza Blvd, Suite 165 SE DECISION MADE: 16-MAY-19
Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS LP Spinal System
Medicrea International S.A. 510(k) NO: K190376(Traditional)
ATTN: David Ryan PHONE NO : 0033 4 72018788
5389 Route De Strasbourg - Vancia SE DECISION MADE: 02-MAY-19
Rillieux-La-Pape FR 69140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
Bioncise NV 510(k) NO: K190378(Traditional)
ATTN: Jaak Janssens PHONE NO : 32 11 271557
Bodemstraat 16 SE DECISION MADE: 24-MAY-19
Wellen BE 3500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wingman 14C Crossing Catheter
ReFlow Medical, Inc. 510(k) NO: K190393(Special)
ATTN: Rebecca K Pine PHONE NO : 760 8095178
208 Avenida Fabricante #100 SE DECISION MADE: 09-MAY-19
San Clemente CA 92672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT MP Reagent System
bioMerieux, Inc. 510(k) NO: K190405(Traditional)
ATTN: Esther Hernandez PHONE NO : 314 7318841
595 Anglum Road SE DECISION MADE: 15-MAY-19
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MatrixRIB Fixation System
DePuy Synthes 510(k) NO: K190409(Traditional)
ATTN: Francoise Cettour-Delbart PHONE NO : 41 61 9656765
1301 Goshen Parkway SE DECISION MADE: 03-MAY-19
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
Roche Molecular Systems, Inc. 510(k) NO: K190433(Traditional)
ATTN: Nobuko Nakajima PHONE NO : 925 7308215
4300 Hacienda Drive SE DECISION MADE: 22-MAY-19
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KATANA Zirconia Block
Kuraray Noritake Dental Inc. 510(k) NO: K190436(Traditional)
ATTN: Yasujiro Ohara PHONE NO : 81 3 67011736
Ote Center Bldg. 7F SE DECISION MADE: 23-MAY-19
Chiyoda-ku JP 100-0004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
Cepheid 510(k) NO: K190441(Traditional)
ATTN: Yi-Ping Lin PHONE NO : 408 4006838
904 Caribbean Drive SE DECISION MADE: 23-MAY-19
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERA I10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K190444(Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 2 21941594
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 22-MAY-19
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LightLas Pattern Scanning System - TruScan Pro
Light-Med(USA), INC. 510(k) NO: K190448(Traditional)
ATTN: Hedy Chiang PHONE NO : 949 2189555
1130 Calle Cordillera SE DECISION MADE: 24-MAY-19
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aptima BV Assay
Hologic, Inc. 510(k) NO: K190452(Traditional)
ATTN: Jeffrey Hergesheimer PHONE NO : 858 4108536
10210 Genetic Center Drive SE DECISION MADE: 23-MAY-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nihon Kohden SVM-7200 Series Vital Signs Monitor
Nihon Kohden Corporation 510(k) NO: K190468(Third Party - Traditional)
ATTN: Thomas Bento PHONE NO : 949 6809048
1-31-4 Nishiochiai, Shinjuku-Ku SE DECISION MADE: 28-MAY-19
Tokyo JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ERBEFLO 2 Disposable Tubing System
Erbe USA, Inc. 510(k) NO: K190469(Traditional)
ATTN: John Tartal PHONE NO : 770 9554400
2225 Northwest Parkway SE DECISION MADE: 23-MAY-19
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aptima CV/TV Assay
Hologic, Inc. 510(k) NO: K190472(Traditional)
ATTN: Jeffrey Hergesheimer PHONE NO : 858 4108536
10210 Genetic Center Drive SE DECISION MADE: 16-MAY-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaLock PEEK Suture Anchor
Medacta International SA 510(k) NO: K190474(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 28-MAY-19
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IGNITE Bone Void Filler
Wright Medical Technology, Inc. 510(k) NO: K190482(Traditional)
ATTN: Alayne Melancon PHONE NO : 901 2905986
1023 Cherry Road SE DECISION MADE: 28-MAY-19
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Recovery Pump, 737R (RPX)
Mego Afek AC Ltd. 510(k) NO: K190493(Traditional)
ATTN: Reuven Yunger PHONE NO : 972 77 984276
Kibbutz Afek SE DECISION MADE: 15-MAY-19
Kibbutz Afek IL 3004200 510(k) STATEMENT
DEVICE: Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
Relievant Medsystems 510(k) NO: K190504(Traditional)
ATTN: Alex DiNello PHONE NO : 650 3681000
358 Moffett Park Drive, Suite 105 SE DECISION MADE: 03-MAY-19
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GuttaSil
Meta Biomed Co., Ltd. 510(k) NO: K190510(Traditional)
ATTN: Suk Song Oh PHONE NO : 82 43 2308959
270, Osong Saengmyeong 1-ro. OsongSE DECISION MADE: 29-MAY-19
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aptima Combo 2 Assay (Panther System)
Hologic, Inc. 510(k) NO: K190515(Traditional)
ATTN: Jeffrey Hergesheimer PHONE NO : 858 4108536
10210 Genetic Center Drive SE DECISION MADE: 23-MAY-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIEVA ULTIRRA Sinus Balloon Catheter
Acclarent, Inc. 510(k) NO: K190525(Traditional)
ATTN: Leena Sorathia PHONE NO : 1 949 9234118
33 Technology Drive SE DECISION MADE: 03-MAY-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruDi NAV Wire
Acclarent, Inc. 510(k) NO: K190532(Traditional)
ATTN: Leena Sorathia PHONE NO : 1 949 9234118
33 Technology Drive SE DECISION MADE: 03-MAY-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Manual Wheelchair SIVFH2A102
Jiangsu Horizon Medical Science & 510(k) NO: K190534(Traditional)
ATTN: Cheng Gong PHONE NO : 86 0511 86808686
No.1 Guanhe Road SE DECISION MADE: 29-MAY-19
Situ Town, DAnyang City CN 212331510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ponto 4
Oticon Medical AB 510(k) NO: K190540(Traditional)
ATTN: Lise Terkelsen PHONE NO : 45 24 225146
Datavagen 37 B SE DECISION MADE: 02-MAY-19
Askim SE SE-436 32 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Soliton Acoustic Wave Device
Soliton Inc. 510(k) NO: K190542(Traditional)
ATTN: Leslie Honda PHONE NO : 206 3758586
5304 Ashbrook Drive SE DECISION MADE: 24-MAY-19
Houston TX 77081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cannulated Hemi Implant
Vilex in Tennessee, Inc. 510(k) NO: K190543(Traditional)
ATTN: Sylvia Southard PHONE NO : 931 4747550
111 Moffitt Street SE DECISION MADE: 31-MAY-19
McMinnville TN 37110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXXT MATRIXX Stand Alone Cervical System
Nexxt Spine LLC 510(k) NO: K190546(Traditional)
ATTN: Andy Elsbury PHONE NO : 317 4367801
14425 Bergen Blvd, Suite B SE DECISION MADE: 31-MAY-19
Noblesville IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASERlipo System
Solta Medical 510(k) NO: K190551(Special)
ATTN: Manal Morcos PHONE NO : 510 2595299
11720 North Creek Pkwy N., Suite 1SE DECISION MADE: 01-MAY-19
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowerX Lipo System
Solta Medical 510(k) NO: K190555(Special)
ATTN: Manal Morcos PHONE NO : 510 2595299
11720 North Creek Pkway N. Suite 1SE DECISION MADE: 01-MAY-19
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
Nonin Medical, Inc. 510(k) NO: K190560(Traditional)
ATTN: Nancy DeAngelo PHONE NO : 763 5339968 2674
13700 1st Avenue North SE DECISION MADE: 02-MAY-19
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cervical Plate
EiserTech, LLC 510(k) NO: K190565(Traditional)
ATTN: Lukas Eisermann PHONE NO : 888 2622817
9988 Hibert Street Suite 302 SE DECISION MADE: 31-MAY-19
San Diego CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KeYi Spinal Fixation System
Beijing KeYi Medical Device Techno510(k) NO: K190567(Traditional)
ATTN: Jenny Jiang PHONE NO : 86 10 67853877
Building 1, 30 Yongchang South RoaSE DECISION MADE: 08-MAY-19
Beijing CN 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAYMAN LP Plate System
K2m, Inc. 510(k) NO: K190584(Traditional)
ATTN: Casey Hinckley PHONE NO : 1 571 9192318
600 Hope Parkway, SE SE DECISION MADE: 15-MAY-19
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aptis Medical Distal Radio Ulnar Joint Implant
Aptis Medical, LLC 510(k) NO: K190599(Traditional)
ATTN: Bryan Babb PHONE NO : 502 4258584___
3602 Glenview Ave. SE DECISION MADE: 03-MAY-19
Glenview KY 40025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tria Firm Ureteral Stent
Boston Scientific Corporation 510(k) NO: K190603(Special)
ATTN: Justin Kapitan PHONE NO : 508 6834518
100 Boston Scientific Way SE DECISION MADE: 24-MAY-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIVO
Velano Vascular 510(k) NO: K190604(Special)
ATTN: Tiffini Wittwer PHONE NO : 844 8352668
221 Pine St #200 SE DECISION MADE: 13-MAY-19
San Francisco CA 94104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
Kossan International Sdn. Bhd. 510(k) NO: K190606(Traditional)
ATTN: Cho Sow Fong PHONE NO : 603 3291 0516
Wisma Kossan, Lot 782, Jalan SungaSE DECISION MADE: 28-MAY-19
Klang MY 42100 510(k) STATEMENT
DEVICE: Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
Medtronic 510(k) NO: K190623(Traditional)
ATTN: Rahul Shah PHONE NO : 763 5149846
7611 Northland Drive SE DECISION MADE: 30-MAY-19
Minneapolis MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexSeal Introducer Sheath with Hydrophilic Coating
Freudenberg Medical MIS, Inc 510(k) NO: K190628(Third Party - Traditional)
ATTN: Larry Bender PHONE NO : 812 2802354
2301 Centennial Boulevard SE DECISION MADE: 30-MAY-19
Jeffersonville IN 47130 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Endosee System
CooperSurgical, Inc. 510(k) NO: K190639(Special)
ATTN: Christine Kupchick PHONE NO : 203 6015200
95 Corporate Drive SE DECISION MADE: 15-MAY-19
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Electrocautery Pencil
Medline Industries, Inc. 510(k) NO: K190643(Traditional)
ATTN: Matt Clausen PHONE NO : 847 6434785
Three Lakes Drive SE DECISION MADE: 06-MAY-19
Northfield IL 60093 510(k) STATEMENT
DEVICE: FUJIFILM Endoscope Model EC-760S-V/L
FUJIFILM Corporation 510(k) NO: K190649(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 07-MAY-19
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYGNUS™ Anterior Cervical Plate System
MiRus, LLC 510(k) NO: K190666(Traditional)
ATTN: Jordan Bauman PHONE NO : 678 3246272
2150 Newmarket Parkway SE DECISION MADE: 09-MAY-19
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOLOC™ 2 Lapidus with Rotation System
Wright Medical Technology, Inc. 510(k) NO: K190670(Traditional)
ATTN: Alayne Melancon PHONE NO : 901 2905986
1023 Cherry Road SE DECISION MADE: 14-MAY-19
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
Siemens Healthcare Diagnostics, In510(k) NO: K190675(Traditional)
ATTN: Laura J. Duggan PHONE NO : 302 6317654
500 GBC Drive SE DECISION MADE: 17-MAY-19
Newark DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optilite IgM CSF Kit
The Binding Site Group Ltd. 510(k) NO: K190686(Traditional)
ATTN: Kanika Darbar PHONE NO : 440 121 4569500
8 Calthorpe Road SE DECISION MADE: 28-MAY-19
Edgbaston GB B15 1qt 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rowheels Revolution 1.0
Rowheels Inc. 510(k) NO: K190699(Traditional)
ATTN: Matthew Doeppers PHONE NO : 608 2689670
8001 Terrace Ave, Ste 204 SE DECISION MADE: 09-MAY-19
Middleton WI 53562 510(k) STATEMENT
DEVICE: Connector System
Orthofix Inc. 510(k) NO: K190751(Traditional)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 22-MAY-19
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Avanto Fit
Siemens Medical Solution USA, Inc.510(k) NO: K190757(Traditional)
ATTN: Cordell L. Fields PHONE NO : 610 4486469
40 Liberty Boulevard Mailcode 65-1SE DECISION MADE: 31-MAY-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurgicalAR
MEDIVIS, Inc. 510(k) NO: K190764(Traditional)
ATTN: Amy Lynn PHONE NO : 954 6008299
20 Jay Street Suite 312 SE DECISION MADE: 13-MAY-19
Brooklyn NY 11201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALACOS fast R+G
Heraeus Medical GmbH 510(k) NO: K190766(Traditional)
ATTN: Ute Greiner PHONE NO : 0049 6181 352808
Philipp-Reis-Strasse 8/13 SE DECISION MADE: 31-MAY-19
Wehrheim DE 61273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bladder Scanner (Models: M2, M2-W, M1, M1-W)
Suzhou Lischka Medtech Co., Ltd. 510(k) NO: K190769(Traditional)
ATTN: Shi Jing PHONE NO : 86 512 36692288 831
NO.999 Qujia Road, Qiandeng Town SE DECISION MADE: 22-MAY-19
Kunshan CN 215341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Envision ultrasound pad and cover
CIVCO Medical Solutions 510(k) NO: K190802(Third Party - Traditional)
ATTN: Jim Leong PHONE NO : 319 6564447
102 First St. South SE DECISION MADE: 24-MAY-19
Kalona IA 52247 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HS Fiber
Riverpoint Medical 510(k) NO: K190817(Special)
ATTN: Edwin Anderson PHONE NO : 503 5178001
825 NE 25th Ave. SE DECISION MADE: 01-MAY-19
Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erbe ESU Model VIO 3 with Accessories
Erbe Elektromedizin GmbH 510(k) NO: K190823(Third Party - Traditional)
ATTN: Julia Weller PHONE NO : 49____ 7071 755172
Waldhoernlestrasse 17 SE DECISION MADE: 22-MAY-19
Tuebingen DE 72072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K190831(Traditional)
ATTN: Zilong Liang PHONE NO : 0086 25 83305050
Suite A, 8/F, Bldg 1, No. 301, HanSE DECISION MADE: 31-MAY-19
Nanjing CN 210036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synchro2 Support Guidewire
Stryker 510(k) NO: K190843(Special)
ATTN: Lorraine Mazzeo PHONE NO : 510 4132676
47900 Bayside Parkway SE DECISION MADE: 01-MAY-19
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K190848(Traditional)
ATTN: Zilong Liang PHONE NO : 0086 25 83305050
Suite A, 8/F, Bldg 1, No. 301, HanSE DECISION MADE: 14-MAY-19
Nanjing CN 210036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDRASHIFT 2/4 daratumumab
Sebia 510(k) NO: K190851(Special)
ATTN: Karen Anderson PHONE NO : 1 770 4463707 3704
1705 Corporate Drive, Suite 400 SE DECISION MADE: 02-MAY-19
Norcross GA 30093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Therm-X
Zenith Technical Innovations 510(k) NO: K190854(Abbreviated)
ATTN: Greg Binversie PHONE NO : 1 847 6727481
1396 St. Paul Ave. SE DECISION MADE: 10-MAY-19
Gurnee IL 60031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Juliet® Ti LL Lumbar Interbody Device
SPINEART 510(k) NO: K190877(Traditional)
ATTN: Franck Pennesi PHONE NO : 41 22 5701200
3 chemin du pre Fleuri SE DECISION MADE: 29-MAY-19
Plan Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Pro510(k) NO: K190879(Special)
ATTN: Christine Perkins PHONE NO : 302 6318811
Emil-von-Behring Str-76 SE DECISION MADE: 03-MAY-19
Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K190896(Traditional)
ATTN: Nimrod Epstein PHONE NO : 972 73 7946870
92 Yigal Alon St. SE DECISION MADE: 31-MAY-19
Tel-Aviv IL 6789134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biograph Vision
Siemens Medical Solutions USA, Inc510(k) NO: K190900(Special)
ATTN: Alaine Medio PHONE NO : 865 8060337
810 Innovation Drive SE DECISION MADE: 06-MAY-19
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope
Wenzhou Renhua Instruments Co., Lt510(k) NO: K190902(Traditional)
ATTN: Wang Saijie PHONE NO : 86 577 86893308
#.1-1704 Wanda Business Building YSE DECISION MADE: 22-MAY-19
Wenzhou CN 325024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTS Doxycycline 0.016 - 256 µg/mL
Liofilchem s. r. l. 510(k) NO: K190914(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 29-MAY-19
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
STERIS Corporation 510(k) NO: K190917(Special)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Road SE DECISION MADE: 09-MAY-19
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioCardia 8.5 F Avance Steerable lntroducer
BioCardia, Inc. 510(k) NO: K190941(Third Party - Traditional)
ATTN: Kevin DeMartini PHONE NO : 650 2260134
125 Shoreway Road, Suite B SE DECISION MADE: 06-MAY-19
San Carlos CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Magic Clear Aligners
Voodoo Manufacturing, Inc. 510(k) NO: K190948(Third Party - Traditional)
ATTN: Max Friefeld PHONE NO : 1 646 8544173
361 Stagg Street #408 SE DECISION MADE: 09-MAY-19
Brooklyn NY 112062 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: D'Vill Introducer
NuMED, Inc. 510(k) NO: K190974(Special)
ATTN: Nichelle LaFlesh PHONE NO : 315 3284491
2880 Main Street SE DECISION MADE: 14-MAY-19
Hopkinton NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAROnova Insufflation System, BAROnova Accessory Kit
BAROnova, Inc. 510(k) NO: K190985(Traditional)
ATTN: Lian Cunningham PHONE NO : 650 6389796
1551 Industrial Road SE DECISION MADE: 14-MAY-19
San Carlos CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6400 Ultrasound System (MyLabX6, MyLabX7)
Esaote, S.p.A. 510(k) NO: K190989(Special)
ATTN: Piet de Jong PHONE NO : 39 055 4229319
Via Enrico Melen 77 SE DECISION MADE: 10-MAY-19
Genova IT 16152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExactVu High Resolution Micro-Ultrasound System
Exact Imaging, Inc. 510(k) NO: K190995(Third Party - Special)
ATTN: Randy AuCoin PHONE NO : 905 4150030
7676 Woodbine Ave., Unit 15 SE DECISION MADE: 10-MAY-19
Markham CA l3r 2n2 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Carnation Ambulatory Monitor
Bardy Diagnostics, Inc 510(k) NO: K191000(Special)
ATTN: Brit Baird PHONE NO : 206 3996938
316 Occidental Avenue South, SuiteSE DECISION MADE: 16-MAY-19
Seattle WA 98104 510(k) STATEMENT
DEVICE: Scope ProTech
Meditech Endoscopy Ltd 510(k) NO: K191011(Third Party - Traditional)
ATTN: Peter Ramsey PHONE NO : 44 1268 534035
Bowden House, Luckyn Lane SE DECISION MADE: 07-MAY-19
Basildon GB ss14 3ax 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
Cook Incorporated 510(k) NO: K191015(Special)
ATTN: Ian Herrman PHONE NO : 812 3353575 104034
750 Daniels Way P.O. Box 489 SE DECISION MADE: 17-MAY-19
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dolphin/IQ, Dolphin/4D and Dolphin/MAX
Viasonix Ltd. 510(k) NO: K191023(Special)
ATTN: Shlomi Deler PHONE NO : 972 5 44301056
10 Hamelacha Street SE DECISION MADE: 16-MAY-19
Raanana IL 4366105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRX-Revolution Mobile X-ray System
Carestream Health Inc. 510(k) NO: K191025(Special)
ATTN: Gina Maiolo PHONE NO : 585 6276543
150 Verona Street SE DECISION MADE: 17-MAY-19
Rochester NY 14608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T-R), Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Model 541TT), Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Model 541TT-R), Affinity NT™ Oxygenator with Cortiva™ BioActive Surface (Model CB511), Affinity NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface (Model CB541)
Medtronic, Inc. 510(k) NO: K191029(Special)
ATTN: Sammie C Joseph-Fredericks PHONE NO : 763 5262337
7611 Northland Drive SE DECISION MADE: 17-MAY-19
Minneapolis MN 55428 510(k) STATEMENT
DEVICE: syngo.via (Version VB40A)
Siemens Healthcare GmbH 510(k) NO: K191040(Third Party - Abbreviated)
ATTN: Elango Alampalayam RangappanPHONE NO : 49 9191 184429
Siemensstr. 1 SE DECISION MADE: 16-MAY-19
Forchheim DE 91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: L10 LED Light Source with AIM, L11 LED Light Source with AIM
Stryker 510(k) NO: K191046(Special)
ATTN: Agatha Szeliga PHONE NO : 604 4227516
5900 Optical Court SE DECISION MADE: 10-MAY-19
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARGOS
SANTEC CORPORATION 510(k) NO: K191051(Third Party - Traditional)
ATTN: Changho Chong PHONE NO : 568 793535
5823 Ohkusa-Nenjozaka SE DECISION MADE: 16-MAY-19
Komaki JP 485-0802 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Arc Endocuff Glide AEG110 & AEG120
Boddingtons Plastics Ltd 510(k) NO: K191067(Special)
ATTN: Shimaa Elsawy PHONE NO : 0044 7801 572833
Wheelbarrow Park Estate, PattendenSE DECISION MADE: 30-MAY-19
Tonbridge GB Tn12 9QJ 510(k) STATEMENT
DEVICE: Ambu aScope 4 RhinoLaryngo Slim
Ambu A/S 510(k) NO: K191080(Special)
ATTN: Gurpreet Kaur Rehal PHONE NO : 45 72 252000
Baltorpbakken 13 SE DECISION MADE: 22-MAY-19
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPLETE CONTROL System Gen2
Coapt, LLC 510(k) NO: K191083(Special)
ATTN: Blair A Lock PHONE NO : 844 2627800
222 W. Ontario Street, Suite #300 SE DECISION MADE: 24-MAY-19
Chicago IL 60654 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rampart One Lumbar Interbody Fusion System
Spineology, Inc. 510(k) NO: K191091(Special)
ATTN: Andrew Adams PHONE NO : 651 2568500
7800 3rd Street North, Suite 600 SE DECISION MADE: 23-MAY-19
Saint Paul MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M RelyX Pediatric Resin Modified Glass Ionomer Cement
3M ESPE Dental Products 510(k) NO: K191122(Third Party - Traditional)
ATTN: Lin Ma PHONE NO : 651 7334734
2510 Conway Ave. SE DECISION MADE: 29-MAY-19
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Swiss LithoClast Trilogy
EMS Electro Medical Systems SA 510(k) NO: K191124(Special)
ATTN: Timothee Deblock PHONE NO : 41 22 9944700
Ch. De la Vuarpilliere 31 SE DECISION MADE: 29-MAY-19
Nyon CH 1260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MasterLock Extension
Medacta International SA 510(k) NO: K191145(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 30-MAY-19
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMR 780, uMR 790
Shanghai United Imaging Healthcare510(k) NO: K191157(Special)
ATTN: Xin Gao PHONE NO : 86 021 67076888 5386
No. 2258 Chengbei Road SE DECISION MADE: 29-MAY-19
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASHK100G
LG Electronics 510(k) NO: K191188(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
222, Lg-ro, Cheongho-ri SE DECISION MADE: 30-MAY-19
Jinwi-myeon Pyeongtaek-si KR 1770510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 246
TOTAL WITH SUMMARIES 230
TOTAL WITH STATEMENTS 16
