510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD December 2019
DEVICE: Pantheon Spinal Pontus Interbody Fusion Device
Pantheon Spinal 510(k) NO: K181548(Traditional)
ATTN: Bob Schultz PHONE NO : 512 2154888
3008 Bee Cave Road, Suite 200 SE DECISION MADE: 16-DEC-19
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental high speed handpiece, Dental low speed handpiece
Foshan CICADA Dental Instrument Co510(k) NO: K181900(Traditional)
ATTN: Juan Liu PHONE NO : 86 757 85775667
B5-2F, Guangdong New Light Source SE DECISION MADE: 09-DEC-19
Foshan CN 528247 510(k) STATEMENT
DEVICE: Krystal Klear Aligners
Shatkin F.I.R.S.T. LLC 510(k) NO: K182388(Traditional)
ATTN: Kimberly Wiesmore PHONE NO : 716 8392959
2495 Kensington Avenue SE DECISION MADE: 19-DEC-19
Amherst NY 14226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
Fengh Medical Co., Ltd. 510(k) NO: K182476(Traditional)
ATTN: Jiao Liu PHONE NO : 0086 138 15132106
D3 No.6 Dongsheng West Road, JiangSE DECISION MADE: 18-DEC-19
Jiangyin CN 214437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mini and Micro Fragments Reconstruction System – GMReis
Gm Dos Reis Industria E Comerico L510(k) NO: K182718(Traditional)
ATTN: Paula Oliveira PHONE NO : 55 19 37659900
Avenida Pierre Simon De La Place 6SE DECISION MADE: 23-DEC-19
Campinas BR 13069320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corelink Navigation Instruments
Corelink LLC 510(k) NO: K182731(Traditional)
ATTN: Steven D. Mounts PHONE NO : 1 888 3497808
7911 Forsyth Blvd, Suite #200 SE DECISION MADE: 13-DEC-19
St. Louis MO 63105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endotracheal Tube with Evacuation Lumen
WELL LEAD MEDICAL CO., LTD. 510(k) NO: K182739(Special)
ATTN: Huang Kaigen PHONE NO : 86 20 84758878
C-4 # Jinhu Industrial Estate, HuaSE DECISION MADE: 11-DEC-19
Guangzhou CN 511434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCI - CMF System
MCI Medical Concept Innovation Inc510(k) NO: K182758(Traditional)
ATTN: Carlos Lacerda PHONE NO : 01 954 3062521
4592 North Hiatus Road SE DECISION MADE: 05-DEC-19
Sunrise FL 33351 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Decanting Device
Gcmedica Enterprise Ltd., (WUXI) 510(k) NO: K182819(Traditional)
ATTN: Mona Zhang PHONE NO : 0086 510 85300900
Loujin Industrial Park, Shuofang SE DECISION MADE: 02-DEC-19
Wuxi CN 214143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genesys Spine 3DP Lumbar Interbody System
Genesys Spine 510(k) NO: K182987(Traditional)
ATTN: William W. Sowers PHONE NO : 512 3817080
1250 South Capital of Texas HighwaSE DECISION MADE: 12-DEC-19
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ID-Cap System
etectRx, Inc. 510(k) NO: K183052(Traditional)
ATTN: Susan Baumgartner PHONE NO : 352 4435713 101
747 SW 2nd Ave Suite 365T, IMB 24 SE DECISION MADE: 06-DEC-19
Gainesville FL 32601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMC 560i
Shanghai United Imaging Healthcare510(k) NO: K183144(Traditional)
ATTN: Shumei Wang PHONE NO : 86 21 67076888 6776
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 19-DEC-19
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IceSense 3, ProSense, MultiSense
IceCure Medical LTD. 510(k) NO: K183213(Traditional)
ATTN: Elisabeth Sadka PHONE NO : 972 52 5670666
7 Haeshel St., P.O. Box 3163 SE DECISION MADE: 20-DEC-19
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deka Tiac 1
El..En. Electroic Engineering SpA 510(k) NO: K183371(Traditional)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
via Baldanzese 17 SE DECISION MADE: 03-DEC-19
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambar, Ambar APS, Ambar Universal APS
DentsCare LTDA 510(k) NO: K183424(Traditional)
ATTN: Roberta Uyara PHONE NO : 55 47 34416131
Av. Edgar Nilson Meister, 474 SE DECISION MADE: 13-DEC-19
Joinville BR 89219-501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NasalCEASE and BleedCEASE
Les Laboratoires Brothier S.A. 510(k) NO: K183622(Traditional)
ATTN: Christian Girardiere PHONE NO : 33 01 56383000
41 rue de Neuilly SE DECISION MADE: 02-DEC-19
Nanterre FR 92735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DentiqAir
3D Industrial Imaging Co., Ltd. 510(k) NO: K183676(Traditional)
ATTN: Bora Choi PHONE NO : 82 70 87669192
Bldg.138, Rm.413, Seoul National USE DECISION MADE: 19-DEC-19
Seoul KR 0882 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carescape One
GE Healthcare 510(k) NO: K190008(Traditional)
ATTN: Joel Kent PHONE NO : 617 8510943
8200 West Tower Avenue SE DECISION MADE: 20-DEC-19
Milwaukee WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
Hong Qiangxing (Shen Zhen) Electro510(k) NO: K190009(Traditional)
ATTN: Xu Jianhua PHONE NO : 86 755 26423615
4F, Jingcheng Building, Xicheng InSE DECISION MADE: 02-DEC-19
Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid
Medtrade Product Ltd 510(k) NO: K190012(Traditional)
ATTN: Mina Patel PHONE NO : 44 01270 500019 276
Electra House, Electra way, Crewe SE DECISION MADE: 18-DEC-19
Crewe GB CW1 6GL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile Zirconia Block
Fine Advanced Compound Co., Ltd 510(k) NO: K190112(Traditional)
ATTN: Jeong Kwang-Ho PHONE NO : 82 31 3589312
7, Galgot-gil, Jinwi-myeon SE DECISION MADE: 20-DEC-19
Pyeongtaek KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Aspiration Needle
Olympus Medical Systems Corp. 510(k) NO: K190239(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 10-DEC-19
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Latex Surgical Glove, Powder Free
Careglove Global Sdn Bhd 510(k) NO: K190241(Traditional)
ATTN: Lim Kwee Shyan PHONE NO : 60 6 6782377
Lot 17479, Lrg Senawang 3/2, Off JSE DECISION MADE: 30-DEC-19
Seremban MY 70450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T3 Platform software
Etiometry, Inc. 510(k) NO: K190273(Traditional)
ATTN: Tim Hanson PHONE NO : 857 3669333
280 Summer St. 4th Floor SE DECISION MADE: 08-DEC-19
Boston MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bengal Stackable Cage System
Medos International SARL 510(k) NO: K190284(Traditional)
ATTN: Linda Bernier PHONE NO : 508 8282837
Chemin-Blanc 38 SE DECISION MADE: 20-DEC-19
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intraocular Pressure Tonometer EASYTON
Company Elamed 510(k) NO: K190382(Traditional)
ATTN: Mikhail Kuzin PHONE NO : 74 912 777598
Yelatma instrument-making enterpriSE DECISION MADE: 06-DEC-19
Yelatma RU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SunClear Aligner system
Sun Dental Laboratories, LLC 510(k) NO: K190394(Traditional)
ATTN: Derek Diasti PHONE NO : 727 5619777
1800 9th Ave N SE DECISION MADE: 16-DEC-19
St. Petersburg FL 33713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iHelmet Hair Growth System
Slinph Technologies Co., LTD 510(k) NO: K190467(Traditional)
ATTN: Zou Jian PHONE NO : 86 158 15568501
Room 211, Building B, 1970 CulturaSE DECISION MADE: 26-DEC-19
Shenzhen CN 518107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVO 450 series High Speed Handpieces
TTBIO CORP. 510(k) NO: K190508(Traditional)
ATTN: Sheng-Chieh Su PHONE NO : 886 4 23595958
2F, No.7, 6th Road Industry Park SE DECISION MADE: 11-DEC-19
Taichung TW 40755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-C Sealer Ion+
Angelus Industria de Produtos Odon510(k) NO: K190537(Abbreviated)
ATTN: Paulo Sergio Calixto De OlivPHONE NO : 55 43 21013205
Rua Waldir Landgraf, 101 SE DECISION MADE: 12-DEC-19
Londrina BR 86.031-218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JJ Implant System
JJ Implants 510(k) NO: K190552(Traditional)
ATTN: Jiju John PHONE NO : 91 984 6008283
IX /214A, Munipara, Kanjirapilly PSE DECISION MADE: 06-DEC-19
Chalakudy IN 680721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Integra TITAN Reverse Shoulder System
Integra LifeSciences Corporation 510(k) NO: K190588(Traditional)
ATTN: Blesson Abraham PHONE NO : 512 8523942
11101 Metric Blvd SE DECISION MADE: 02-DEC-19
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUINOX Balloon Dilatation Catheter
Dornier MedTech America Inc 510(k) NO: K190612(Traditional)
ATTN: John Hoffer PHONE NO : 770 5146163
1155 Roberts Blvd, Suite 100 SE DECISION MADE: 06-DEC-19
Kennesaw GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NanoOrtho NanoKnee® System
NanoOrtho, LLC 510(k) NO: K190633(Traditional)
ATTN: Austin Ferro PHONE NO : 805 7148984
860 Oak Park Blvd STE 301 SE DECISION MADE: 20-DEC-19
Arroyo Grande CA 93420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
Zimmer Inc. 510(k) NO: K190656(Traditional)
ATTN: Charles Neitzel PHONE NO : 262 7163243
P.O. Box 708 SE DECISION MADE: 06-DEC-19
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip
Allwin Medical Devices, Inc. 510(k) NO: K190659(Traditional)
ATTN: Digish Mehta PHONE NO : 714 5721709
3305 E. Mira Loma Avenue, Suite 17SE DECISION MADE: 02-DEC-19
Anaheim CA 92806 510(k) STATEMENT
DEVICE: G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene
Zimmer, Inc. 510(k) NO: K190660(Traditional)
ATTN: Mary Wentorf PHONE NO : 574 5279517
P.O. Box 708 SE DECISION MADE: 05-DEC-19
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Instrument Kit Cases
JJGC Industria e Comercio de Mater510(k) NO: K190665(Traditional)
ATTN: Luiza Vaccari Toppel PHONE NO : 55 41 21694150
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 23-DEC-19
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Health Expert Electronic Stimulator
Shenzhen OSTO Technology Company L510(k) NO: K190673(Traditional)
ATTN: Li Yang PHONE NO : 86 755 29769546
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 12-DEC-19
Longgang District, Shenzhen City 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
Interscope, Inc. 510(k) NO: K190715(Traditional)
ATTN: Jeffery Ryan PHONE NO : 877 4207299
100 Main Street, Suite 108 SE DECISION MADE: 13-DEC-19
Whitinsville MA 01588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer, model: PC808
Shenzhen Pacom Medical Instruments510(k) NO: K190717(Traditional)
ATTN: Xuewen Chen PHONE NO : 86 755 32920339
8th floor of B District, B BuildinSE DECISION MADE: 13-DEC-19
Shenzhen CN 518105 510(k) STATEMENT
DEVICE: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
Riverstone Resources SDN BHD 510(k) NO: K190725(Traditional)
ATTN: Suresh Kumar PHONE NO : 603 60283033
Lot 56, No 15, Jalan Jasmin 2 SE DECISION MADE: 17-DEC-19
Bukit Beruntung MY 48300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IODOSORB
Smith & Nephew Medical Ltd. 510(k) NO: K190730(Traditional)
ATTN: Meenakshi Gupta PHONE NO : 901 3996139
101 Hessle Road SE DECISION MADE: 20-DEC-19
Hull East Riding of Yorkshire GB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs
Ever Growth (Vietnam) Co. Ltd. 510(k) NO: K190736(Abbreviated)
ATTN: Ming Lee PHONE NO : 84 61 3514025
Long Khanh Industrial Zone BinhlocSE DECISION MADE: 23-DEC-19
Binhloc Village VN 810000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyShoulder Placement Guides
Medacta International SA 510(k) NO: K190738(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 13-DEC-19
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIFLO-28
Neogenix, LLC dba Ogenix 510(k) NO: K190742(Traditional)
ATTN: Srinivasan Sarangapani PHONE NO : 781 7026732
3401 Enterprise Pkwy, Suite 340 SE DECISION MADE: 13-DEC-19
Beachwood OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Satisfaite
FemmePharma Consumer Healthcare, L510(k) NO: K190752(Traditional)
ATTN: Gerianne DiPiano PHONE NO : 610 9950801 18
175 Strafford Ave., Bldg 4, Suite SE DECISION MADE: 13-DEC-19
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IODOFLEX
Smith & Nephew Medical Ltd. 510(k) NO: K190756(Traditional)
ATTN: Meenakshi Gupta PHONE NO : 901 3996139
10 I Hessle Road SE DECISION MADE: 20-DEC-19
Hull East Riding Of Yorkshire GB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The RHEA Vital Sign Vigilance System
Shenzhen Fiber Medical Technology 510(k) NO: K190775(Traditional)
ATTN: Luo Li PHONE NO : 86 1857 76650186
Room 501, Sun Mate Science and TecSE DECISION MADE: 19-DEC-19
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tablo Hemodialysis System, Tablo Cartridge
Outset Medical, Inc. 510(k) NO: K190793(Traditional)
ATTN: Jennifer Mascioli-Tudor PHONE NO : 669 2318200
1830 Bering Drive SE DECISION MADE: 12-DEC-19
San Jose CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL
PENTAX of America, Inc. 510(k) NO: K190805(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 20-DEC-19
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric
Bluepoint Medical GmbH & Co. KG 510(k) NO: K190824(Traditional)
ATTN: Bernd Lindner PHONE NO : 49 38823 5488000
An der Trave 15 SE DECISION MADE: 18-DEC-19
Selmsdorf DE 23923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
Wilson-Cook Medical, Inc. / Cook E510(k) NO: K190829(Traditional)
ATTN: Tiffanny A Thomas PHONE NO : 336 7440157 396680
4900 Bethania Station Road SE DECISION MADE: 19-DEC-19
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXS Vecta Aspiration Catheter
Stryker Neurovascular 510(k) NO: K190833(Traditional)
ATTN: Shazia Hakim PHONE NO : 510 4132636
47900 Bayside Parkway SE DECISION MADE: 15-DEC-19
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color
Ever Growth (Vietnam) Co. Ltd. 510(k) NO: K190860(Abbreviated)
ATTN: Ming Lee PHONE NO : 84 61 3514025
Long Khanh Industrial Zone BinhlocSE DECISION MADE: 23-DEC-19
Binhloc Village VN 810000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
Mercator Medical (Thailand) LTD. 510(k) NO: K190876(Traditional)
ATTN: Dariusz Jan Krezymon PHONE NO : 66 74 584222
88/8, 88/9 Moo 12 Tambon KampaengpSE DECISION MADE: 02-DEC-19
Amphur Rattaphum TH 90180 510(k) STATEMENT
DEVICE: Spinal Elements Navigated Instruments
Spinal Elements Inc 510(k) NO: K190881(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071840
3115 Melrose Dr. Suite 200 SE DECISION MADE: 19-DEC-19
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
Datascope Corp. 510(k) NO: K190884(Traditional)
ATTN: Mark Dinger PHONE NO : 973 7097691
15 Law Drive SE DECISION MADE: 26-DEC-19
Fairfield NJ 07004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lawson Retrograde Nephrostomy Wire Puncture Set
Cook Incorporated 510(k) NO: K190903(Traditional)
ATTN: Andrew Breidenbach PHONE NO : 812 3353575 105147
750 Daniels Way SE DECISION MADE: 16-DEC-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: xvision Spine system (XVS)
Augmedics Ltd. 510(k) NO: K190929(Traditional)
ATTN: Tami Harel PHONE NO : 972 4 3730111
1 Ha-Tsmikha St SE DECISION MADE: 20-DEC-19
Yokneam lllit IL 2069205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZER, Portable X-ray System
Livermoretech Inc. 510(k) NO: K190935(Traditional)
ATTN: Jae Hong Kim PHONE NO : 1 214 2570113
801 North Jupiter Rd, Suite 200 SE DECISION MADE: 19-DEC-19
Plano TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL Arrhythmia Management Sysyem
ZOLL Manufacturing Corporation 510(k) NO: K190939(Traditional)
ATTN: Zachary Nelson PHONE NO : 412 9683333 14814
121 Gamma Drive SE DECISION MADE: 19-DEC-19
Pittsburgh PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIA Benzodiazepine Assay
Microgenics Corporation 510(k) NO: K190968(Traditional)
ATTN: Minoti Patel PHONE NO : 510 9795000
45600 Kato Road SE DECISION MADE: 09-DEC-19
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uroject12 Syringe Lever
UroGen Pharma Ltd. 510(k) NO: K190987(Special)
ATTN: Liz Schindel PHONE NO : 972 9 7707600
9 Ha`Ta`asiya Street SE DECISION MADE: 02-DEC-19
Ra’anana IL 4365405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Thermometer
Xiamen Ants Bro Technology Co., Lt510(k) NO: K190990(Traditional)
ATTN: Jane Xu PHONE NO : 86 592 6537633
4th & 5th Floor, No.5 Building, TeSE DECISION MADE: 31-DEC-19
Xiamen CN 361026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Southern Implants MAX Implant System
Southern Implants (Pty) Ltd 510(k) NO: K191054(Traditional)
ATTN: Lauranda G. Breytenbach PHONE NO : 27 12 6671046
1 Albert Road SE DECISION MADE: 09-DEC-19
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Rad-97 and Accessories
Masimo Corporation 510(k) NO: K191059(Traditional)
ATTN: Linus Park PHONE NO : 949 2977000
52 Discovery SE DECISION MADE: 27-DEC-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exciplex
Clarteis 510(k) NO: K191086(Traditional)
ATTN: Laurent Meilhac PHONE NO : 33 954 039377
WTC2, 120 route des macarons SE DECISION MADE: 11-DEC-19
Valbonne FR 06560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntraMarX Radiopaque Markers
AnX Robotica Corp. 510(k) NO: K191087(Traditional)
ATTN: Lin Wang PHONE NO : 510 4492263
7213 Regency Court SE DECISION MADE: 18-DEC-19
Plano TX 75204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Checkme O2 Pulse Oximeter
Shenzhen Viatom Technology Co., Lt510(k) NO: K191088(Traditional)
ATTN: Zhou Saixin PHONE NO : 86 755 86638929
4E, Building 3, Tinwei Industrial SE DECISION MADE: 02-DEC-19
Baoan District Guandong CN 518101510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C50 and C80 Multi-parameter Patient Monitor
Shenzhen Comen Medical Instruments510(k) NO: K191106(Traditional)
ATTN: Hongbo Yan PHONE NO : 86 1342 4152596
Floor 11 and Section C of Floor 12SE DECISION MADE: 13-DEC-19
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avanti Distal Radius and Forearm System
Avanti Orthopaedics, Inc. 510(k) NO: K191118(Traditional)
ATTN: J. Doug Patterson PHONE NO : 302 5306369
4606 Simon Road SE DECISION MADE: 13-DEC-19
Wilmington DE 19803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumax Guiding Catheter
Cook Incorporated 510(k) NO: K191163(Traditional)
ATTN: David Lehr PHONE NO : 812 3392235 102309
750 Daniels Way SE DECISION MADE: 12-DEC-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System - Temporary Abutments
JJGC Industria e Comercio de Mater510(k) NO: K191191(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694058
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 05-DEC-19
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets
Erbe Elektromedizin GmbH 510(k) NO: K191234(Traditional)
ATTN: Henry Kutz PHONE NO : 0049 7071 7550
Waldhoernlestrasse 17 SE DECISION MADE: 20-DEC-19
Tuebingen DE 72072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart Peak Flow Meter
Guangzhou Homesun Medical Technolo510(k) NO: K191239(Traditional)
ATTN: Jinqun Li PHONE NO : 86 020 34003801
Floor 7th, TianxiangBusiness BuildSE DECISION MADE: 06-DEC-19
Guangzhou CN 510250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Southern Implants PEEK Abutments
Southern Implants (Pty) Ltd 510(k) NO: K191250(Traditional)
ATTN: Lauranda Breytenbach PHONE NO : 27 12 6671046
1 Albert Road SE DECISION MADE: 05-DEC-19
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann BLX Ø3.5 mm Implants
Institut Straumann AG 510(k) NO: K191256(Traditional)
ATTN: Ana C. M. Vianna PHONE NO : 41 61 9651512
Peter Merian Weg 12 SE DECISION MADE: 27-DEC-19
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable SpO2 Sensor
Shenzhen Caremed Medical Technolog510(k) NO: K191279(Traditional)
ATTN: Alan Xie PHONE NO : 86 755365 60977889
East Side, 3/F, C Building, KeluntSE DECISION MADE: 06-DEC-19
Dalang Office, Longhua District, S510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hereaeus Poseidon Microcatheter
Heraeus Medical Components, LLC 510(k) NO: K191305(Traditional)
ATTN: Chelsea Pioske PHONE NO : 763 2256500
2605 Fernbrook Lane North, Suite JSE DECISION MADE: 19-DEC-19
Plymouth MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Llis, Vittra APS
Dentscare LTDA 510(k) NO: K191306(Traditional)
ATTN: Roberta Uyara PHONE NO : 55 47 34416131
Av. Edgar Nelson Meister, 474 SE DECISION MADE: 16-DEC-19
Joinville BR 89219-501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
Chongqing Sunkingdom Medical Instr510(k) NO: K191314(Traditional)
ATTN: Shulin Guo PHONE NO :
1012, Block A of China Resource CeSE DECISION MADE: 19-DEC-19
Chongqing CN 400050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVE® Free Testosterone RIA
Immunotech s.r.o. 510(k) NO: K191350(Special)
ATTN: Vit Oburka PHONE NO : 420 272 017368
Radiova 1 SE DECISION MADE: 20-DEC-19
Prague CZ 10227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MolecuLight i:X
MolecuLight Inc. 510(k) NO: K191371(Traditional)
ATTN: Anil Amlani PHONE NO : 416 5425530
Suite 700, 425 University Avenue SE DECISION MADE: 04-DEC-19
Toronto CA M5G 1T6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELiZORB
Alcresta Therapeutics, Inc. 510(k) NO: K191379(Traditional)
ATTN: Eric First PHONE NO : 617 4313600
One Newton Executive Park, Suite 1SE DECISION MADE: 04-DEC-19
Newton MA 02462 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Nonin Medical, Inc. 510(k) NO: K191403(Traditional)
ATTN: Walter Holbein PHONE NO : 763 5775504
13700 1st Avenue North SE DECISION MADE: 20-DEC-19
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paragonix SherpaPak Pancreas Transport System
Paragonix Technologies 510(k) NO: K191440(Traditional)
ATTN: Lisa M. Anderson PHONE NO : 1 781 4284828
Suite 408, 639 Granite St. SE DECISION MADE: 20-DEC-19
Braintree MA 02184 510(k) STATEMENT
DEVICE: Straumann Modular Cassette
Institut Straumann AG 510(k) NO: K191522(Traditional)
ATTN: Jenni Vescovo PHONE NO : 41 61 9651292
Peter Merian-Weg 12 SE DECISION MADE: 03-DEC-19
Basel CH 4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIST Cath Radial Access Long Sheath
RIST Neurovascular, Inc. 510(k) NO: K191551(Traditional)
ATTN: Marianne Grumwaldt PHONE NO : 305 4953883
11611 Interchange Circle S SE DECISION MADE: 23-DEC-19
Miramar FL 33025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioSticker System
BioIntelliSense Inc. 510(k) NO: K191614(Traditional)
ATTN: Henry Leung PHONE NO : 408 6556027
570 El Camino Real, Suite 200 SE DECISION MADE: 18-DEC-19
Redwood City CA 94063 510(k) STATEMENT
DEVICE: SleepTight Mouthpiece STZ
Michael D Williams DDS PA 510(k) NO: K191618(Traditional)
ATTN: Michael Williams PHONE NO : 954 4759154
10991 SW 42ND PL SE DECISION MADE: 11-DEC-19
Davie FL 33328 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TK Sterile Hypodermic Needle
Anhui Tiankang Medical Technology 510(k) NO: K191643(Traditional)
ATTN: Bai Baodong PHONE NO : 86 550 7309187
NO.228 Weiyi Road, Economic DeveloSE DECISION MADE: 19-DEC-19
Tianchang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QLAB Advanced Quantification Software
Philips Healthcare 510(k) NO: K191647(Traditional)
ATTN: Eri Gremi PHONE NO : 978 6592980
22100 Bothell Everett Highway SE DECISION MADE: 20-DEC-19
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zipbond
SDI Limited 510(k) NO: K191656(Traditional)
ATTN: Ray Cahill PHONE NO : 61 3 87277111
3-15 Brunsdon Street SE DECISION MADE: 02-DEC-19
Bayswater AU 3153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unscented W long plastic and cardboard applicator tampons
ONTEX BVBA 510(k) NO: K191666(Traditional)
ATTN: Henri Lesage PHONE NO : 32 52 454611
5 Genthof SE DECISION MADE: 20-DEC-19
Buggenhout Oost - Vlaanderen BE 9510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Stethoscope
Hefei Mintti Medical Technology Co510(k) NO: K191667(Traditional)
ATTN: Shengsheng Cai PHONE NO : 86 0551 63638810
C309, National University Science SE DECISION MADE: 18-DEC-19
Hefei CN 230088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
Cook Biotech Incorporated 510(k) NO: K191696(Traditional)
ATTN: Perry W. Guinn PHONE NO : 765 4973355
1425 Innovation Place SE DECISION MADE: 27-DEC-19
West Lafayette IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EyeStat
Blinktbi Inc. 510(k) NO: K191700(Traditional)
ATTN: Ryan Fiorini PHONE NO : 843 5078995
635 Rutledge Ave., Suite 102 SE DECISION MADE: 09-DEC-19
Charleston SC 29403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vital Navigation System
Zimmer Biomet Spine, Inc. 510(k) NO: K191722(Traditional)
ATTN: Alex Pawlowski PHONE NO : 303 5331062
10225 Westminster Drive SE DECISION MADE: 02-DEC-19
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EM Provisional
Hiossen, Inc. 510(k) NO: K191751(Abbreviated)
ATTN: Peter Lee PHONE NO : 888 6780001
85 Ben Fairless Drive SE DECISION MADE: 16-DEC-19
Fairless Hills PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
Argon Medical Devices, Inc. 510(k) NO: K191758(Traditional)
ATTN: Jo Huang PHONE NO : 903 6779237
1445 Flat Creek Road SE DECISION MADE: 17-DEC-19
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Quick Switch Valve with ENFit Connector
Medline Industries, Inc. 510(k) NO: K191759(Traditional)
ATTN: Dinah Rincones PHONE NO : 847 9792687
Three Lakes Drive SE DECISION MADE: 04-DEC-19
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICO 14 Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited 510(k) NO: K191760(Traditional)
ATTN: Sam Greenhalgh PHONE NO : 44 1482 673436
101 Hessle Road SE DECISION MADE: 05-DEC-19
Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System
Nebula Surgical Private Limited 510(k) NO: K191793(Traditional)
ATTN: Rajat Kumar Khant PHONE NO : 91 281 2584832
Nebula, Narmada Park-3,Amin Marg, SE DECISION MADE: 09-DEC-19
Rajkot IN 360005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neo Cage System
Neo Medical S.A. 510(k) NO: K191796(Traditional)
ATTN: Jonas Larsson PHONE NO : 41 22 5483880
Route de Lausanne 157A SE DECISION MADE: 13-DEC-19
Villette (Lavaux) CH 1096 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOMi Scope
PhotoniCare, Inc. 510(k) NO: K191804(Traditional)
ATTN: Ryan Shelton PHONE NO : 405 8807209
60 Hazelwood Dr. SE DECISION MADE: 05-DEC-19
Champaign IL 61820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear-Aligners
CDB Corporation 510(k) NO: K191823(Traditional)
ATTN: Leah M. Lehman PHONE NO : 910 3836464
9201 Industrial Blvd SE DECISION MADE: 20-DEC-19
Leland NC 28451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stand-Alone ALIF Titanium System
Life Spine Inc. 510(k) NO: K191834(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 16-DEC-19
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceramill A-Splint
Amann Girrbach AG 510(k) NO: K191836(Traditional)
ATTN: Debora Engel PHONE NO : 49 7231 957260
Herrschaftswiesen 1 SE DECISION MADE: 20-DEC-19
Koblach AT 6842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXReach Laser Probe
Vortex Surgical Inc. 510(k) NO: K191846(Traditional)
ATTN: Bob Neu PHONE NO : 636 7784350
680 Crown Industrial Ct. Suite F SE DECISION MADE: 23-DEC-19
Chesterfield MO 63005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aurora Surgiscope System
Rebound Therapeutics 510(k) NO: K191861(Traditional)
ATTN: Naomi Gong PHONE NO : 949 3048111
13900 Alton Parkway Suite 120 SE DECISION MADE: 06-DEC-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21HK512D
LG Electronics Inc. 510(k) NO: K191864(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
222, LG-ro, Cheongho-ri, Jinwi-myeSE DECISION MADE: 05-DEC-19
Pyeongtaek-si KR 17709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRX-Evolution with Carestream Digital Tomosynthesis
Carestream Health, Inc. 510(k) NO: K191879(Traditional)
ATTN: Duane Gutowski PHONE NO : 585 6278760
150 Verona Street SE DECISION MADE: 20-DEC-19
Rochester NY 14608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
Innovative Health, LLC. 510(k) NO: K191880(Traditional)
ATTN: Amanda Babcock PHONE NO : 480 5255911
1435 North Hayden Road, Suite 100 SE DECISION MADE: 11-DEC-19
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann Mini Implants
Institut Straumann AG 510(k) NO: K191895(Traditional)
ATTN: Viviana Horhoiu PHONE NO : 41 61 9651512
Peter Merian Weg 12 SE DECISION MADE: 09-DEC-19
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Latex Powder-Free Surgical Gloves
Modern Healthcare Corp. 510(k) NO: K191898(Traditional)
ATTN: Ke-Min Jen PHONE NO : 886 4 8752116
No. 751, Chung Chou Road, Sec. 2, SE DECISION MADE: 18-DEC-19
Chang-Hwa TW 520456 510(k) STATEMENT
DEVICE: Arthrex Univers Revers Modular Glenoid System
Arthrex Inc. 510(k) NO: K191960(Special)
ATTN: Ivette Galmez PHONE NO : 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 23-DEC-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitra 2
Quantel Medical 510(k) NO: K191962(Traditional)
ATTN: Bruno Pages PHONE NO : 33 473 745732
11 Rue du Bois Joli-CS40015 SE DECISION MADE: 05-DEC-19
Cournon D'Auvergne-Cedex FR 63808510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unyvero LRT BAL Application
Curetis GmbH 510(k) NO: K191967(Traditional)
ATTN: Karsten Mueller PHONE NO : 49 7031 4919510
Max-Eyth-Straße 42 SE DECISION MADE: 20-DEC-19
Holzgerlingen DE 71088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BC Reflex Uni Knee System
Bodycad Laboratories, Inc. 510(k) NO: K191996(Traditional)
ATTN: Guy Sevigny PHONE NO : 418 5271388
2035, rue du Haut-Bord SE DECISION MADE: 05-DEC-19
Quebec City CA g1n 4r7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Blood Pressure Monitor
Truly Instrument Limited 510(k) NO: K192023(Abbreviated)
ATTN: Su HaiSen PHONE NO : 86 0660 3363561
Site 2, Truly Industry Area SE DECISION MADE: 23-DEC-19
ShanWei CN 516600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEREWOLF COBLATION System, COBLATION HALO Wand
Arthrocare Corporation 510(k) NO: K192027(Traditional)
ATTN: Shruthi Bhat PHONE NO : 512 8951295
7000 West William Cannon Drive SE DECISION MADE: 20-DEC-19
Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Emprint Visualization Application
Covidien LLC. 510(k) NO: K192038(Traditional)
ATTN: Janna Babson PHONE NO : 303 8768721
5920 Longbow Drive SE DECISION MADE: 02-DEC-19
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIEW Modeler
Coreline Soft Co., Ltd 510(k) NO: K192040(Traditional)
ATTN: Hyeyi Park PHONE NO : 82 2 5717321
4, 5F (Yeonnam-dong), 49, World CuSE DECISION MADE: 20-DEC-19
Seoul KR 03991 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4CIS Marlin PEEK ACIF Cage
Solco Biomedical Co., Ltd. 510(k) NO: K192044(Traditional)
ATTN: Hwi-geun Yu PHONE NO : 82 31 6644101
154 Seotan-ro, Seotan-myeon SE DECISION MADE: 19-DEC-19
Pyeongtaek-Si KR 17704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aveta Disposable Hysteroscope
Meditrina, Inc. 510(k) NO: K192100(Special)
ATTN: Csaba Truckai PHONE NO : 408 4714877
1190 Saratoga Avenue, Suite 180 SE DECISION MADE: 19-DEC-19
San Jose CA 95129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)
Medline Industries, Inc. 510(k) NO: K192104(Traditional)
ATTN: Claire Pigman PHONE NO : 847 6434071
Three Lakes Drive SE DECISION MADE: 23-DEC-19
Northfield IL 60093 510(k) STATEMENT
DEVICE: Icobrain
Icometrix NV 510(k) NO: K192130(Traditional)
ATTN: Dirk Smeets PHONE NO : 32 16 369000
Kolonel Begaultlaan 1b/12 SE DECISION MADE: 13-DEC-19
Leuven BE 3012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Beachside System
SeaSpine Orthopedics Corporation 510(k) NO: K192132(Traditional)
ATTN: Aly Alvarez PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 03-DEC-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
MicroVention, Inc. 510(k) NO: K192135(Traditional)
ATTN: Sapna Singh PHONE NO : 714 2478162
1311 Valencia Ave. SE DECISION MADE: 24-DEC-19
Tustin CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS Dental Implant System
Dentsply Sirona Inc. 510(k) NO: K192149(Traditional)
ATTN: Karl J. Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street SuiteSE DECISION MADE: 11-DEC-19
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K192152(Traditional)
ATTN: Zhang Wei PHONE NO : 86 755 81885655
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 13-DEC-19
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R&D Series Nova Compo N
Imicryl Dis Malzemeleri Sanayi Ve 510(k) NO: K192178(Traditional)
ATTN: Husamettin Sonmez PHONE NO : 0090 444 7130
Fetih Mahallesi Mahir Sokak No:5/2SE DECISION MADE: 20-DEC-19
Konya TR 42030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avenir Complete Hip System, Size 0 Coxa Vara
Zimmer, Inc. 510(k) NO: K192189(Traditional)
ATTN: Rebecca D Noftz PHONE NO : 574 3732934
P.O. Box 708 SE DECISION MADE: 18-DEC-19
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Radiation Dosimetry System microSTARii
Landauer 510(k) NO: K192196(Traditional)
ATTN: Matt Ennis PHONE NO : 1 800 3238830
2 Science Rd. SE DECISION MADE: 27-DEC-19
Glenwood IL 60425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReliOn Premier Classic Blood Glucose Monitoring System
i-SENS, Inc. 510(k) NO: K192220(Special)
ATTN: Joon Ho Jung PHONE NO : 82 2 9100455
43, Banpo-daero 28-gil, Seocho-gu SE DECISION MADE: 13-DEC-19
Seoul KR 06646 510(k) STATEMENT
DEVICE: BTL-899
BTL 510(k) NO: K192224(Traditional)
ATTN: David Chmel PHONE NO : 866 2851656
362 Elm Street SE DECISION MADE: 05-DEC-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses
VizionFocus, Inc. 510(k) NO: K192225(Traditional)
ATTN: Angus Shih PHONE NO : 037 582900
No.66, Youyi Rd. SE DECISION MADE: 09-DEC-19
Zhunan Township TW 350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System- GM Titanium Base for Bridge
JJGC Industria e Comercio de Mater510(k) NO: K192229(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 412169 4000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 19-DEC-19
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode System with Tone Applicator
InMode Ltd. 510(k) NO: K192249(Traditional)
ATTN: Amit Goren PHONE NO : 972 49097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 17-DEC-19
Yokneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Valve Sets
Zhejiang Chuangxiang Medical Techn510(k) NO: K192258(Traditional)
ATTN: Lucius Long PHONE NO : 86 057189 670888099
301B, No.22, XinYan Road SE DECISION MADE: 30-DEC-19
Hanzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILUMIEN System with AptiVue Software version D.3
Abbott Medical 510(k) NO: K192267(Special)
ATTN: Anita Xavier PHONE NO : 978 5773400
4 Robbins Road SE DECISION MADE: 17-DEC-19
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PhantomMSK Trauma
OrthoGrid Systems Inc. 510(k) NO: K192279(Traditional)
ATTN: Sebastian Edin PHONE NO : 801 70035866
3216 South Highland, Suite 202 SE DECISION MADE: 07-DEC-19
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transpara
Screenpoint Medical B.V. 510(k) NO: K192287(Traditional)
ATTN: Umar Waqas PHONE NO : 31 24 3030045
Mercator II, 7th floor, ToernooiveSE DECISION MADE: 10-DEC-19
Nijmegen NL 6525EC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halo One Thin-Walled Guiding Sheath
C.R. Bard, Inc. 510(k) NO: K192313(Traditional)
ATTN: Elizabeth Delahunty PHONE NO : 353 53 9237111
Moyne Upper SE DECISION MADE: 19-DEC-19
Enniscorthy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K192319(Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 22194 1594
3366, Hanseo-ro, Nam-myeon, SE DECISION MADE: 10-DEC-19
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sheridan Spiral-Flex Endotracheal Tubes
TeleflexMedical, Inc 510(k) NO: K192324(Traditional)
ATTN: Lori Pfohl PHONE NO : 919 4918960
3015 Carrington Mill Blvd , Suite SE DECISION MADE: 06-DEC-19
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACKER Kyphoplasty System
GS Medical Co., Ltd. 510(k) NO: K192335(Traditional)
ATTN: Andrea Watt PHONE NO : 82 352 3274641
90, Osongsaengmyeong 4-ro SE DECISION MADE: 04-DEC-19
Osong-eup, Cheongwon-gun KR 363-9510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptoMonitor
Opsens Inc 510(k) NO: K192340(Traditional)
ATTN: Marc Chaunet PHONE NO : 418 7810333 3408
750 Boulevard du Parc TechnologiquSE DECISION MADE: 12-DEC-19
Quebec CA GIP 4S3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Monitor
Shenzhen Creative Industry Co., Lt510(k) NO: K192343(Traditional)
ATTN: Jia Wang PHONE NO : 86 755 26433325
Floor 5, BLD 9 Baiwangxin High-TecSE DECISION MADE: 31-DEC-19
Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SICAT Implant V2.0
SICAT GmbH & Co. KG 510(k) NO: K192348(Traditional)
ATTN: Manfred Breuer PHONE NO : 49 228 85469782
Brunnenallee 6 SE DECISION MADE: 04-DEC-19
Bonn DE 53177 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Airlock Centrolock Osteosynthesis Implant System
NOVASTEP 510(k) NO: K192356(Traditional)
ATTN: Gilles Audic PHONE NO : 33 029933 8650
Espace Performance III- Batiment PSE DECISION MADE: 14-DEC-19
Saint-Gregoire FR 35769 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aero Blue Performance Surgical Gowns
O&M Halyard, Inc. 510(k) NO: K192362(Abbreviated)
ATTN: Kimberly Lewis PHONE NO :
9120 Lockwood Blvd SE DECISION MADE: 13-DEC-19
Mechanicsville VA 23116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
Bayer Medical Care, Inc. 510(k) NO: K192370(Traditional)
ATTN: Alison Maloney PHONE NO : 862 4048106
100 Bayer Blvd SE DECISION MADE: 13-DEC-19
Whippany NJ 07981 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
Cardinal Health 200, LLC 510(k) NO: K192374(Traditional)
ATTN: Dominic Tunzi PHONE NO : 312 2702172
3651 Birchwood Drive SE DECISION MADE: 02-DEC-19
Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K192383(Traditional)
ATTN: Nimrod Epstein PHONE NO : 972 73 7946870
3 Aminadav St. SE DECISION MADE: 20-DEC-19
Tel-Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hi-Fatigue Bone Cement
OSARTIS GmbH 510(k) NO: K192394(Traditional)
ATTN: Volker Stirnal PHONE NO : 49 6071 9290
Lagerstrasse 11-15 SE DECISION MADE: 02-DEC-19
Dieburg DE 64807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZS3 and z.one pro Ultrasound Systems
ShenZhen Mindray Bio-Medical Elect510(k) NO: K192410(Traditional)
ATTN: Jiang Haosen PHONE NO : 86 755 81886183
Keji 12th Road South, High-tech InSE DECISION MADE: 19-DEC-19
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epic 980
Biolase, Inc. 510(k) NO: K192430(Special)
ATTN: Alicia Mszyca PHONE NO : 949 2268471
4 Cromwell SE DECISION MADE: 04-DEC-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETi Peripheral Thrombectomy System
Walk Vascular, LLC 510(k) NO: K192439(Traditional)
ATTN: David Look PHONE NO : 949 7529642
17171 Daimler Street SE DECISION MADE: 09-DEC-19
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FFRangio
CathWorks Ltd 510(k) NO: K192442(Special)
ATTN: Asaf Azulay PHONE NO : 972 9 7467387
3 Rapaport Street SE DECISION MADE: 09-DEC-19
Kfar-Saba IL 4465141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dextile Anatomical Mesh
Sofradim Production 510(k) NO: K192443(Traditional)
ATTN: Benjamin Rochette PHONE NO : 33 474 089000
116 avenue du Formans SE DECISION MADE: 06-DEC-19
Trevoux FR 01600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: mCare® Powder Free Nitrile Black Examination Glove
Mercator Medical (Thailand) LTD. 510(k) NO: K192444(Traditional)
ATTN: Praneet Inthajak PHONE NO : 66 74584 222
88/8 Moo 12 Tambon Kampaengphet SE DECISION MADE: 31-DEC-19
Amphur Rattaphum TH 90180 510(k) STATEMENT
DEVICE: Precision Casting Solutions Total Hip System
Precision Casting Solution, LLC 510(k) NO: K192450(Traditional)
ATTN: Jim Moore PHONE NO : 503 4211251
200031 Henrici Road SE DECISION MADE: 17-DEC-19
Oregon City OR 97045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DenMat Orthodontic Aligners
DenMat Holdings, LLC 510(k) NO: K192470(Third Party - Traditional)
ATTN: Tom Juarez PHONE NO : 805 3463700
1017 W. Central Avenue SE DECISION MADE: 20-DEC-19
Lompoc CA 93436 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RHIN1 Stylus
Aerin Medical Inc. 510(k) NO: K192471(Traditional)
ATTN: Matthew M Hull PHONE NO : 737 2144035
232 E Caribbean Dr. SE DECISION MADE: 20-DEC-19
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exsomed Wrist Plating System
Exsomed Corporation 510(k) NO: K192473(Traditional)
ATTN: Michael Zwolinski PHONE NO : 855 3976633
135 Columbia, Suite 201 SE DECISION MADE: 03-DEC-19
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elekta Unity
Elekta Limited 510(k) NO: K192482(Traditional)
ATTN: Nicholas Power PHONE NO : 0044 1293 654422
Fleming Way SE DECISION MADE: 05-DEC-19
Crawley GB RH10 9RR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioCode Respiratory Pathogen Panel (RPP)
Applied BioCode, Inc. 510(k) NO: K192485(Traditional)
ATTN: Robert Di Tullio PHONE NO : 310 8011235
10020 Pioneer Blvd Suite 102 SE DECISION MADE: 23-DEC-19
Santa Fe Springs CA 90670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-TRAX Containment Device
K1 Medical LLC 510(k) NO: K192487(Traditional)
ATTN: Joseph Azary PHONE NO : 203 2426670
56 Newton Road SE DECISION MADE: 23-DEC-19
Woodbridge CT 06525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS50/HS60 Diagnostics Ultrasound System
Samsung Medison CO., LTD. 510(k) NO: K192505(Traditional)
ATTN: Scully Kim PHONE NO : 82 2 21941312
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 12-DEC-19
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOSPA II Knee System
Corentec Co., Ltd 510(k) NO: K192507(Traditional)
ATTN: J.S. Daniel PHONE NO : 82 41 5857144
12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 11-DEC-19
Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser 808nm
Beijing Superlaser Technology Co.,510(k) NO: K192516(Traditional)
ATTN: Shi Shuang PHONE NO : 86 10 81284899 806
No. 2 Zhongfu Street, Economic andSE DECISION MADE: 10-DEC-19
Xihongmen Town, Daxing District, B510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intense Pulsed Light Treatment System
Shangdong Huamei Technology Co., L510(k) NO: K192521(Traditional)
ATTN: Xu QingHua PHONE NO : 86 536211 0001
No. 588, Changning Street, High-teSE DECISION MADE: 06-DEC-19
Weifang CN 261205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSV BellaTek Express and BellaTek Flex Abutments
Biomet 3i LLC 510(k) NO: K192522(Traditional)
ATTN: Krupal Patel PHONE NO : 561 7766923
4555 Riverside Drive SE DECISION MADE: 09-DEC-19
Palm Beach Gardens FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 Laser Therapy System
Shangdong Huamei Technology Co., L510(k) NO: K192528(Traditional)
ATTN: Xu QingHua PHONE NO : 86 536 2110001
No. 588, Changning Street, High-teSE DECISION MADE: 03-DEC-19
Weifang CN 261205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QyScore Software
Qynapse 510(k) NO: K192531(Traditional)
ATTN: Olivier Courreges PHONE NO :
67 rue Saint Jacques SE DECISION MADE: 13-DEC-19
Paris FR 75005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Health Line CT CVC
Health Line International Corporat510(k) NO: K192533(Traditional)
ATTN: Joel K. Faulkner PHONE NO : 801 7737798
5675 W 300 S SE DECISION MADE: 10-DEC-19
Salt Lake City UT 84117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deka Luxea
El..EN. Electronic Engineering SPA510(k) NO: K192539(Traditional)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8226807
via Baldanzese 17 SE DECISION MADE: 16-DEC-19
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: decimal3D
.decimal, LLC. 510(k) NO: K192554(Traditional)
ATTN: Kevin Erhart PHONE NO : 407 3303300
121 Central Park PL SE DECISION MADE: 13-DEC-19
Sanford FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acetabular Bone Screws (for MobileLink Acetabular Cup System)
Waldemar Link GmbH & Co. KG 510(k) NO: K192559(Special)
ATTN: Karen Sonnenberger PHONE NO : 49 40 53995517
Oststraße 4-10 SE DECISION MADE: 21-DEC-19
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Therapy System
San He Lefis Electronics Co., Ltd.510(k) NO: K192569(Traditional)
ATTN: Ning Li PHONE NO : 86 188 11392951
No. 1 Production Room., ChaoBai StSE DECISION MADE: 13-DEC-19
YanJiao Development Zone, Sanhe Co510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NemoScan
Software Nemotec S.L. 510(k) NO: K192571(Traditional)
ATTN: Carlos Arias PHONE NO : 34 91 4335222
Juan de la Cierva Street, 66 SE DECISION MADE: 11-DEC-19
Arroyomolinos, Madrid ES 28939 510(k) STATEMENT
DEVICE: CNS Envision
Moberg Research, Inc. 510(k) NO: K192572(Traditional)
ATTN: Anna Rodriguez PHONE NO : 215 2830860
224 S. Maple Street SE DECISION MADE: 17-DEC-19
Ambler PA 19002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InCore TMT System
Nextremity Solutions, Inc. 510(k) NO: K192578(Traditional)
ATTN: Elise Fox PHONE NO : 574 3762062
210 North Buffalo Street SE DECISION MADE: 31-DEC-19
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
Ethicon, Inc 510(k) NO: K192580(Traditional)
ATTN: Eleanor Zhou PHONE NO :
Route 22 West, P.O. Box 151 SE DECISION MADE: 18-DEC-19
Somerville NJ 00876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEACON Caresystem Model 00002144
Mermaid Care A/S 510(k) NO: K192584(Traditional)
ATTN: Claus Lindholt PHONE NO : 45 70 237015
Hedelund 1 SE DECISION MADE: 18-DEC-19
Norresundby DK DK-0400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Everyway OTC TENS/EMS Combination
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K192589(Traditional)
ATTN: Paul Hung PHONE NO : 886 2 26620038
3 FL., NO. 5, Lane 155, Section 3,SE DECISION MADE: 19-DEC-19
Shenkeng District, New Taipei City510(k) STATEMENT
DEVICE: ExSpiron 2Xi
Respiratory Motion 510(k) NO: K192595(Special)
ATTN: Susan K. Hamann PHONE NO : 781 3731636
80 Coolidge Hill Road SE DECISION MADE: 17-DEC-19
Watertown MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LiteWalk
Viasonix Ltd. 510(k) NO: K192607(Traditional)
ATTN: Shlomi Deler PHONE NO : 972 9744 1692
10 Hamelacha Street SE DECISION MADE: 19-DEC-19
Raananna IL 4366105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)
Synovis Life Technologies, Inc. (B510(k) NO: K192615(Traditional)
ATTN: Megan Sajjad PHONE NO : 651 7967410
2575 University Ave. W SE DECISION MADE: 17-DEC-19
St. Paul MN 55114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laser Hair Growth Cap
Shang Fa Biotechnology Co. 510(k) NO: K192627(Traditional)
ATTN: Chung Ju Zhi PHONE NO : 886 967 001688
B1F., No. 6, Ln. 1, Qingli St., TuSE DECISION MADE: 13-DEC-19
New Taipei City TW 23677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spinalytics
Optima Health Solutions Internatio510(k) NO: K192629(Traditional)
ATTN: Farhad Ghani PHONE NO : 1 604 2665338
Unit 303 - 828 W 8th Avenue SE DECISION MADE: 21-DEC-19
Vancouver CA V5Z 1E2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trigon™ Ti Stand-Alone Wedge Fixation System
Nvision Biomedical Technologies, I510(k) NO: K192645(Traditional)
ATTN: Diana Langham PHONE NO : 210 5453713
4754 Shavano Oak, Suite 101 SE DECISION MADE: 23-DEC-19
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: neria guard Infusion Set
Unomedical a/s 510(k) NO: K192647(Traditional)
ATTN: Mette Busk Henningsen PHONE NO : 45 4022 1704
Aaholmvej 1-3 SE DECISION MADE: 13-DEC-19
Osted DK DK-4320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Depuy Synthes Maxillofacial Portfolio - MR Conditional
Synthes (USA) Products LLC 510(k) NO: K192655(Traditional)
ATTN: Satapa Dhamankar PHONE NO : 610 7196574
1301 Goshen Parkway SE DECISION MADE: 30-DEC-19
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
Promisemed Hangzhou Meditech Co., 510(k) NO: K192666(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 12, Longtan Road, Cangqian StrSE DECISION MADE: 02-DEC-19
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Instrument Kit Cases
JJGC Industria e Comercio de Mater510(k) NO: K192670(Traditional)
ATTN: Luiza Vaccari Toppel PHONE NO : 55 41 21694058
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 18-DEC-19
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Percusys® Plus Pedicle Screw System
Joimax GmbH 510(k) NO: K192680(Traditional)
ATTN: Gary Mocnik PHONE NO : 949 4330413
Amalienbadstr. 41, RaumFabrik 61 SE DECISION MADE: 18-DEC-19
Karlsruhe DE 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode System with the Morpheus8 (Fractora) Applicators
Inmode MD Ltd. 510(k) NO: K192695(Special)
ATTN: Amit Goren PHONE NO : 972 4909 7470
Tabor Building, Shaar Yokneam SE DECISION MADE: 27-DEC-19
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xcam
HDX WILL Corp. 510(k) NO: K192700(Traditional)
ATTN: Myoung-Joon Lee PHONE NO : 82 43 7107318
#105,106,201,202,203,204,38,OsongsSE DECISION MADE: 27-DEC-19
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dannik Titanium Ligation Clip
Dannik 510(k) NO: K192711(Traditional)
ATTN: Olga Haberlad PHONE NO : 407 7451698
941 W Morse Blvd. Suite 100 SE DECISION MADE: 20-DEC-19
Winter Park FL 32789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
Pioneer Surgical Technology, Inc.,510(k) NO: K192718(Traditional)
ATTN: Linda Busklein PHONE NO : 888 4551061
375 River Park Circle SE DECISION MADE: 20-DEC-19
Marquette MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RelieforMe TENS/EMS Device Model UPK-GE01
Umeheal Ltd. 510(k) NO: K192733(Traditional)
ATTN: Rui Lin PHONE NO : 0086 0755 36646865
Floor 5, Bld F4, 1001 ZhongshanyuaSE DECISION MADE: 23-DEC-19
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORRIDOR Fixation System
Globus Medical Inc. 510(k) NO: K192744(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800
2560 General Armistead Ave. SE DECISION MADE: 16-DEC-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Soli-Lite LG4 Galileo
Silhouet-Tone Corporation 510(k) NO: K192755(Traditional)
ATTN: Eric Ghedin PHONE NO : 1 450 6879456 101
2185 Michelin SE DECISION MADE: 20-DEC-19
Laval CA H7L 5B8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Physio Flex Annuloplasty Ring
Edwards Lifesciences LLC 510(k) NO: K192762(Traditional)
ATTN: Milinda Mawley PHONE NO : 949 2505847
One Edwards Way SE DECISION MADE: 16-DEC-19
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT CaScoring
Siemens Medical Solutions USA, Inc510(k) NO: K192763(Traditional)
ATTN: Tabitha Estes PHONE NO : 865 8044553
810 Innovation Drive SE DECISION MADE: 17-DEC-19
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Intraoral Imaging Plate System
Fsusen Technology Co., Ltd 510(k) NO: K192766(Traditional)
ATTN: Elsa Li PHONE NO : 86 0755 29588956
1F, 3# Building, Tongfuyu IndustriSE DECISION MADE: 05-DEC-19
Shenzhen CN 518055 510(k) STATEMENT
DEVICE: Temporary Fixation Pins
EiserTech, LLC 510(k) NO: K192768(Traditional)
ATTN: Lukas Eisermann PHONE NO : 901 2218406
9988 Hibert Street Suite 302 SE DECISION MADE: 26-DEC-19
San Diego CA 32131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLIVE
Nu Eyne Co., Ltd 510(k) NO: K192773(Traditional)
ATTN: Dong Seong Lee PHONE NO : 82 2 69538120
#403, Seoul Biohub, 117-3 Hoegi-roSE DECISION MADE: 06-DEC-19
Seoul KR 02455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Demetra BDEM-01 Dermatoscope
Barco NV 510(k) NO: K192829(Traditional)
ATTN: Julie Vandecandelaere PHONE NO : 32 56 262319
President Kennedypark 35 SE DECISION MADE: 13-DEC-19
Kortrijk BE 8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indigo Aspiration System
Penumbra, Inc. 510(k) NO: K192833(Traditional)
ATTN: Teri Nguyen PHONE NO : 510 9952012
One Penumbra Place SE DECISION MADE: 20-DEC-19
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SX-One MicroKnife
Sonex Health, Inc. 510(k) NO: K192873(Traditional)
ATTN: Aaron Keenan PHONE NO : 507 2191464
11 1st Ave SW SE DECISION MADE: 20-DEC-19
Rochester MN 55902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. Mobility Scooter HS-268
Chien Ti Enterprise Co., Ltd. 510(k) NO: K192885(Traditional)
ATTN: Vivian Lo PHONE NO : 886 2 29032987
No. 13, Lane 227, Fu Ying Rd SE DECISION MADE: 09-DEC-19
New Taipei City, Hsin Chuang Distr510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AutoMIStar
Apollo Medical Imaging Technology 510(k) NO: K192912(Third Party - Traditional)
ATTN: Qing Yang PHONE NO : 61 3 99956190
Suite 611 365 Little Collins StreeSE DECISION MADE: 31-DEC-19
Melbourne AU Vic 3000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
STERIS Corporation 510(k) NO: K192929(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 10-DEC-19
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invictus™ Spinal Fixation System
Alphatec Spine, Inc. 510(k) NO: K192938(Traditional)
ATTN: Cynthia Adams PHONE NO : 706 4946740
5818 El Camino Real SE DECISION MADE: 12-DEC-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Volumetric Specimen Imager
Clarix Imaging 510(k) NO: K192939(Traditional)
ATTN: Xiao han PHONE NO : 773 9542735
2242 Harrison St Suite 201 SE DECISION MADE: 27-DEC-19
Chicago IL 60612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIA Heroin Metabolite (6-AM) assay
Microgenics Corporation 510(k) NO: K192943(Traditional)
ATTN: Sharron Penn PHONE NO : 510 9795000
46500 Kato Road SE DECISION MADE: 16-DEC-19
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Litho Evo
Quanta System spa 510(k) NO: K192990(Traditional)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 376797
via Acquedotto 109 SE DECISION MADE: 20-DEC-19
Samarate (Va) IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Albumin BCP
Sentinel CH. SpA 510(k) NO: K193001(Traditional)
ATTN: Patricia Dupe PHONE NO : 39 02 34551496
Via Robert Koch, 2 SE DECISION MADE: 19-DEC-19
Milano IT 20152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monopolar Cord
New Deantronics Taiwan Ltd 510(k) NO: K193004(Traditional)
ATTN: Jane Liu PHONE NO : 886 2 22681726
12F., No.51, Sec.4, Chong Yang Rd.SE DECISION MADE: 19-DEC-19
New Taipei City TW 23675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promisemed Heel Blood Lancet
Promisemed Hangzhou Meditech Co., 510(k) NO: K193009(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571887 72985
No. 12, Longtan Road, Cangqian StrSE DECISION MADE: 03-DEC-19
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Direct Hand-held Laparoscopic Instruments
Surgical Direct, Inc. 510(k) NO: K193018(Traditional)
ATTN: David Murray PHONE NO : 386 7381202 222
909 South Woodland Blvd. SE DECISION MADE: 20-DEC-19
DeLand FL 32720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VenaPro Vascular Therapy System
Innovamed Health, LLC 510(k) NO: K193020(Special)
ATTN: Luke Zeutzius PHONE NO : 972 7959269
270 West 500 North SE DECISION MADE: 04-DEC-19
North Salt Lake UT 84054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD Mark 7 Arterion Injection System
Bayer Medical Care Inc. 510(k) NO: K193028(Special)
ATTN: Kelly Frank PHONE NO : 412 5767583
1 Bayer Drive SE DECISION MADE: 05-DEC-19
Indianola PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avenir Muller Stem, Avenir Cemented Hip Stem
Zimmer GmbH 510(k) NO: K193030(Special)
ATTN: Roberto Tommasini PHONE NO : 41 58854 8264
Sulzerallee 8 SE DECISION MADE: 06-DEC-19
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Balloon Dilator V (with knife)
Olympus Medical Systems Corp. 510(k) NO: K193039(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-machi SE DECISION MADE: 17-DEC-19
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
Zimmer GmbH 510(k) NO: K193050(Special)
ATTN: Roberto Tommasini PHONE NO : 41 58 8548264
Sulzerallee 8 SE DECISION MADE: 26-DEC-19
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIROS 8 Sequential Compression Device
AIROS Medical, Inc. 510(k) NO: K193068(Special)
ATTN: Darren Behuniak PHONE NO : 1 866 9916956
2501 Monroe Blvd. Suite 1200 SE DECISION MADE: 04-DEC-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIROS 6 Sequential Compression Device
AIROS Medical, Inc. 510(k) NO: K193069(Special)
ATTN: Darren Behuniak PHONE NO : 1 866 9916956
2501 Monroe Blvd. Suite 1200 SE DECISION MADE: 04-DEC-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bashir Plus Endovascular Catheter
Thrombolex, Inc. 510(k) NO: K193071(Traditional)
ATTN: Amy Katsikis PHONE NO : 267 8983986
75 New Britain Dr. SE DECISION MADE: 17-DEC-19
New Britain PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
Medacta International SA 510(k) NO: K193083(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 03-DEC-19
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriSalus Infusion System
TriSalus Life Sciences 510(k) NO: K193107(Third Party - Traditional)
ATTN: Patrick McCain PHONE NO : 703 3140030
6272 W. 91st Avenue SE DECISION MADE: 03-DEC-19
Westminster CO 80031 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MRopen EVO
ASG Superconductors S.p.A. 510(k) NO: K193116(Special)
ATTN: DeBenedetti Luisella PHONE NO : 39 010 6489358
Corso Ferdinando Maria Perrone 73/SE DECISION MADE: 20-DEC-19
Genova IT 16152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Distal Cap Models 33-40
FUJIFILM Corporation 510(k) NO: K193123(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 11-DEC-19
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-TORQUE InfilTrac Guide Wire Family
Abbott Vascular 510(k) NO: K193126(Special)
ATTN: Aniket Khakhadiya PHONE NO : 408 8458314
3200 Lakeside Drive SE DECISION MADE: 11-DEC-19
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
Hangzhou Clongene Biotech Co.,Ltd.510(k) NO: K193132(Traditional)
ATTN: Zheng Shujian PHONE NO : 86 571 88262120
Building 4, No.20 Longquan Road, YSE DECISION MADE: 11-DEC-19
Hangzhou CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
Cook Incorporated 510(k) NO: K193133(Special)
ATTN: Irasema Rivera PHONE NO : 812 3353575 105116
750 Daniels Way SE DECISION MADE: 12-DEC-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSolution One Total Knee Application
Think Surgical, Inc. 510(k) NO: K193135(Special)
ATTN: Meliha Mulalic PHONE NO : 510 2492337
47201 Lakeview Blvd SE DECISION MADE: 11-DEC-19
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VaPro Plus Pocket, VaPro Plus
Hollister Incorporated 510(k) NO: K193148(Special)
ATTN: Michelle Schiltz-Taing PHONE NO : 847 6802122
2000 Hollister Drive SE DECISION MADE: 13-DEC-19
Libertyville IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: True 3D Viewer Software
EchoPixel Inc. 510(k) NO: K193149(Third Party - Traditional)
ATTN: Michael Gabler PHONE NO : 408 2058670
4677 Old Ironsides Suite 445 SE DECISION MADE: 27-DEC-19
Santa Clara CA 95054 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Arthrex 3.9mm Corkscrew Suture Anchor
Arthrex Inc. 510(k) NO: K193157(Special)
ATTN: Jessica L. Singelais PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard SE DECISION MADE: 12-DEC-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glidesheath Slender Tibial Pedal Kit
Terumo Medical Coporation 510(k) NO: K193160(Special)
ATTN: Liang Lu PHONE NO : 410 3927321
950 Elkton Blvd. SE DECISION MADE: 03-DEC-19
Elkton MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPi-Sense Guided Coagulation System with VisiTrax
AtriCure, Inc. 510(k) NO: K193162(Special)
ATTN: Caitlin Wunderlin PHONE NO : 513 7554100
7555 Innovation Way SE DECISION MADE: 13-DEC-19
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
Luminex Molecular Diagnostics, Inc510(k) NO: K193167(Special)
ATTN: Jennifer Grimes PHONE NO : 1 437 3715516
439 University Avenue SE DECISION MADE: 11-DEC-19
Toronto CA M5g 1y8 510(k) STATEMENT
DEVICE: Deep Learning Image Reconstruction
GE Healthcare Japan Corporation 510(k) NO: K193170(Special)
ATTN: Tomohiro Ito PHONE NO : 262 42428222
7-127, 4-Chome, Asahigaoka, SE DECISION MADE: 13-DEC-19
Hino JP 191-8503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CareView 1800Le
CareRay Digital Medical System Co.510(k) NO: K193173(Special)
ATTN: Leilei Li PHONE NO : 86 512 86860288
A2-201/B3-501, Biobay, 218 Xinghu SE DECISION MADE: 13-DEC-19
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Keos Lumbar IBFD
Keos 510(k) NO: K193174(Special)
ATTN: Scott Peterson PHONE NO : 239 2591491
1824 Colonial Village Lane SE DECISION MADE: 16-DEC-19
Lancaster PA 17601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EV1000 Clinical Platform
Edwards Lifesciences, LLC 510(k) NO: K193179(Special)
ATTN: Jamie Byun PHONE NO : 949 2500808
One Edwards Way SE DECISION MADE: 17-DEC-19
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CrossTorq 14 Guidewire
Scientia Cardio Access LLC 510(k) NO: K193194(Third Party - Traditional)
ATTN: Amy McManus PHONE NO : 1 888 3859016
3487 West 2100 South Suite 100 SE DECISION MADE: 13-DEC-19
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EXALT Model D Single-Use Duodenoscope, EXALT Controller
Boston Scientific Corporation 510(k) NO: K193202(Traditional)
ATTN: Carter Navarro PHONE NO : 508 6834793
100 Boston Scientific Way SE DECISION MADE: 13-DEC-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G Surgical Marksman System
G Surgical LLC 510(k) NO: K193219(Special)
ATTN: Donald Grafton PHONE NO : 512 4944749
9433 Bee Cave Road Building 3, SuiSE DECISION MADE: 17-DEC-19
Austin TX 78733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ziehm Vision FD
Ziehm Imaging GmbH 510(k) NO: K193230(Special)
ATTN: Steve Seeman PHONE NO : 49 0911 2172 219
Donaustrasse 31 SE DECISION MADE: 20-DEC-19
Nuremberg DE 90451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Telepack +
Karl Storz Endoscopy America, Inc.510(k) NO: K193235(Special)
ATTN: Winkie Wong PHONE NO : 424 2188379
2151 E. Grand Ave SE DECISION MADE: 20-DEC-19
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nexus DR Digital X-Ray Imaging System (with vSharp)
Varex Imaging Corporation 510(k) NO: K193238(Special)
ATTN: Michael Van Ryn PHONE NO : 315 2346800
121 Metropolitan Drive SE DECISION MADE: 20-DEC-19
Liverpool NY 13088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Attest Steam Chemical Integrator
3M Company 510(k) NO: K193254(Special)
ATTN: Mary Fretland PHONE NO : 651 7372296
3M Center, Building 275-5W-06 SE DECISION MADE: 23-DEC-19
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UroLift System (UL400)
Neotract, Inc. 510(k) NO: K193269(Special)
ATTN: Brian Gall PHONE NO : 925 3296547
4155 Hopyard Rd. SE DECISION MADE: 20-DEC-19
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comet II Pressure Guidewire
Boston Scientific Corporation 510(k) NO: K193279(Special)
ATTN: Kimberly Berg PHONE NO : 763 4942701
Three Scimed Place SE DECISION MADE: 23-DEC-19
Maple Grove MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
Applied Medical Resources Corp. 510(k) NO: K193292(Special)
ATTN: Blake Stacy PHONE NO : 949 7138163
22872 Avenida Empresa SE DECISION MADE: 20-DEC-19
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoreLite X-Ray Specimen Cabinet
Cirdan Imaging Limited 510(k) NO: K193317(Third Party - Traditional)
ATTN: Jenna McGarry PHONE NO : 011 4428 92660880
8 Enterprise Crescent, BallinderrySE DECISION MADE: 13-DEC-19
Lisburn GB BT28 2BP 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Tri-Ex Extraction Balloon with Multiple Sizing
Wilson-Cook Medical Inc. 510(k) NO: K193344(Special)
ATTN: Theresa de Prat PHONE NO : 336 7440157 396518
4900 Bethania Station Road SE DECISION MADE: 13-DEC-19
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadCalc Software
LifeLine Software, Inc. 510(k) NO: K193381(Special)
ATTN: Craig Laughton PHONE NO : 903 2074298 13
3304 S Broadway Ave, Suite 200 SE DECISION MADE: 31-DEC-19
Tyler TX 75701 510(k) STATEMENT
DEVICE: UroNav System
Invivo Corporation 510(k) NO: K193403(Third Party - Traditional)
ATTN: Kym Rupp PHONE NO : 452 87 7127
3545 SW 47th Ave SE DECISION MADE: 27-DEC-19
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 265
TOTAL WITH SUMMARIES 249
TOTAL WITH STATEMENTS 16
