Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 50
- Latest Decision
- 2018-11-01
Clearances · page 18 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K180363 | Clear-Tip EUS-FNA | Finemedix Co., Ltd. | FCG | Class II | 2018-11-01 |
| K181994 | Single Use Aspiration Needle NA-U201H | Olympus Medical Systems Corp. | FCG | Class II | 2018-10-31 |
| K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | Cook Incorporated | KOB | Class II | 2018-10-30 |
| K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | KOD | Class II | 2018-10-30 |
| K182540 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | FDF | Class II | 2018-10-30 |
| K182381 | Wilson-Cook Mini Basket | Wilson-Cook Medical, Inc. | LQR | Class II | 2018-10-30 |
| K180285 | PENTAX Medical Video Colonoscope EC34-i10T Series | Pentax Medical of America, Inc. | FDF | Class II | 2018-10-26 |
| K180258 | SpeediCath Standard | Coloplast | GBM | Class II | 2018-10-25 |
| K182140 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | NAY | Class II | 2018-10-24 |
| K180605 | GastroFlush | Bionix Development Corporation | KNT | Class II | 2018-10-24 |
| K180622 | Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port | Covidien | KNT | Class II | 2018-10-23 |
| K182735 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies | MSB | Class II | 2018-10-19 |
| K181803 | Medax Biopsy Systems III | Medax Srl Unipersonale | KNW | Class II | 2018-10-18 |
| K180708 | Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit | Xeridiem Medical Devices, A Spectrum Plastics Group Company | PIF | Class II | 2018-10-18 |
| K180418 | Reliant(TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | FGE | Class II | 2018-10-15 |
| K180292 | PENTAX Video Upper G.I. Scope EG34-i10 | Pentax Medical of America, Inc. | FDS | Class II | 2018-10-12 |
| K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | Jiangsu Micsafe Medical Technology Co., Ltd. | PNR | Class II | 2018-10-11 |
| K181517 | Senhance Surgical System | Transenterix, Inc. | NAY | Class II | 2018-10-09 |
| K182490 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | FEO | Class II | 2018-10-09 |
| K182122 | Ureteric Catheters | Coloplast Corp. | EYB | Class II | 2018-10-04 |
| K182051 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | FDT | Class II | 2018-10-02 |
| K181445 | AMSure Hydrophilic Intermittent Catheter | Amsino International, Inc. | EZD | Class II | 2018-10-01 |
| K180216 | Seidmon Antegrade AQ Stent Set | Cook Incorporated | FAD | Class II | 2018-09-28 |
| K180068 | ORISE Gel | Boston Scientific | PLL | Class II | 2018-09-28 |
| K181608 | Disposable Standard Clamp | Standard Bariatrics | GCJ | Class II | 2018-09-27 |
| K181991 | NxStage Connected Health System | Nxstage Medical, Inc. | FKP | Class II | 2018-09-26 |
| K171947 | SOLOASSIST II | Aktormed GmbH | NAY | Class II | 2018-09-21 |
| K180029 | Malecot Nephrostomy Catheter/Stent Set | Cook Incorporated | FAD | Class II | 2018-09-21 |
| K181616 | PSM 3-Way Silicone Foley Catheter | Pathway, LLC | EZL | Class II | 2018-09-21 |
| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm | United States Endoscopy Group, Inc. | FEQ | Class II | 2018-09-21 |
| K180781 | Bard Vertus Foley Catheter | C.R. Bard, Inc. | EZL | Class II | 2018-09-19 |
| K182080 | Scope Antifogging System | Xodus Medical, Inc. | GCJ | Class II | 2018-09-19 |
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter | Cook Incorporated | EYB | Class II | 2018-09-14 |
| K182275 | Seal Single Use Biopsy Valve | Boston Scientific Corporation | OCX | Class II | 2018-09-13 |
| K180053 | Sof-Flex Ureteral Stent Set | Cook Incorporated | FAD | Class II | 2018-09-13 |
| K173822 | Anchor Tissue Retrieval System by CONMED | Conmed Corporation | GCJ | Class II | 2018-09-11 |
| K182144 | Bi-Flex Evo | Promepla Sam | KNY | Class II | 2018-09-07 |
| K181811 | ReTrace Ureteral Access Sheath | Coloplast A/S | FED | Class II | 2018-09-07 |
| K173921 | HD-500 Video Endoscope System | Sonoscape Medical Corp. | NWB | Class II | 2018-09-05 |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | Amsino International, Inc. | EZL | Class II | 2018-09-04 |
| K182024 | Dissecting Balloon System | Applied Medical Resources Corp. | GCJ | Class II | 2018-08-30 |
| K181997 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | FEO | Class II | 2018-08-30 |
| K173673 | AcuSnare Polypectomy Snare | Wilson-Cook Medical, Inc. | FDI | Class II | 2018-08-24 |
| K173657 | Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter | Cook Incorporated | EZL | Class II | 2018-08-23 |
| K181439 | SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation | FBN | Class II | 2018-08-23 |
| K181791 | SIMPLYSTRONG, SIMPLYEZEE | Genicon, Inc. | GCJ | Class II | 2018-08-21 |
| K182004 | PENTAX Medical Endoscopic Ultrasound System | Pentax of America, Inc. | ODG | Class II | 2018-08-21 |
| K171890 | BEXCORE Breast Biopsy System, Biopsy Needle | Medical Park Co., Ltd. | KNW | Class II | 2018-08-20 |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | Convatec Limited | GBM | Class II | 2018-08-16 |
| K181909 | Luminelle DTx Hysteroscopy System | Uvision360, Inc. | FAJ | Class II | 2018-08-16 |
| K181977 | WiScope Digital Endoscope System | OTU Medical, Inc. | FGB | Class II | 2018-08-14 |
| K180351 | EndoWrist Mercury Bipolar Grasper | Intuitive Surgical, Inc. | NAY | Class II | 2018-08-07 |
| K181346 | CystoSure Plus Catheter | Emmy Medical, LLC | EZL | Class II | 2018-08-06 |
| K180341 | FUJIFILM 600 Series Endoscope EG-600WR v2 | Fujifilm Corporation | FDS | Class II | 2018-08-03 |
| K181395 | Universal Cannula Seal (5-12 mm) | Intuitive Surgical, Inc. | GCJ | Class II | 2018-07-27 |
| K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender | Covidien, LLC | FJS | Class II | 2018-07-27 |
| K181763 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | FDS | Class II | 2018-07-27 |
| K181712 | San Antonio Stopcock | Cook Incorporated | ODC | Class II | 2018-07-26 |
| K173585 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | NAY | Class II | 2018-07-19 |
| K180977 | KARL STORZ New Generation Trocars | KARL STORZ Endoscopy-America, Inc. | GCJ | Class II | 2018-07-18 |
| K173654 | Ureteral Dilator Sets, Ureteral Dilators | Cook Incorporated | EZN | Class II | 2018-07-17 |
| K173340 | Yikang Latex Foley Catheter | Jiangxi Yikang Medical Instrument Group Co., Ltd. | EZL | Class II | 2018-07-13 |
| K181276 | CONOD Enteral Feeding Sets | Conod Medical Co., Limited | PIF | Class II | 2018-07-12 |
| K180725 | Aspire Introducer Needle | Aspire Bariatrics, Inc. | KNT | Class II | 2018-07-11 |
| K181522 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope | Pentax of America, Inc. | FDT | Class II | 2018-07-09 |
| K180868 | Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set | Cook Ireland | FGE | Class II | 2018-07-06 |
| K173659 | Howell D.A.S.H Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | GCA | Class II | 2018-07-06 |
| K181509 | Endorate Valve Sets | Smartdata Suzhou Co., Ltd. | OCX | Class II | 2018-07-06 |
| K180018 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | KGE | Class II | 2018-07-05 |
| K173721 | SureForm 60 and SureForm 60 Reloads | Intuitive Surgical | NAY | Class II | 2018-07-05 |
| K181175 | 12F Tri-Flow Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | NIE | Class II | 2018-07-05 |
| K180367 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | FGB | Class II | 2018-07-03 |
| K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | Pentax of America, Inc. | PEA | Class II | 2018-07-03 |
| K172556 | TubeClear System | Actuated Medical, Inc. | KNT | Class II | 2018-06-29 |
| K173164 | Ecolab POU Water Filter | Ecolab, Inc. | NHV | Class II | 2018-06-29 |
| K180481 | Servator B SALF Solution | S.A.L.F. Spa | KDN | Class II | 2018-06-29 |
| K180134 | Ensizor Monopolar Endoscopic Scissors | Slater Endoscopy, LLC | KGE | Class II | 2018-06-29 |
| K180583 | LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD | Richard Wolf Medical Instruments Corporation | FET | Class II | 2018-06-28 |
| K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | KOD | Class II | 2018-06-28 |
| K181141 | OverStitch Endoscopic Suturing System and Accessories | Apollo Endosurgery | OCW | Class II | 2018-06-27 |
| K173414 | Advance Biliary Balloon Catheter | Cook Incorporated | GCA | Class II | 2018-06-22 |
| K180824 | VaPro 2 Intermittent Catheter | Hollister Incorporated | GBM | Class II | 2018-06-22 |
| K170826 | Perfadex Plus | Xvivo Perfusion AB | KDN | Class II | 2018-06-22 |
| K181437 | Pure Vu System | Motus GI Medical Technologies , Ltd. | FDF | Class II | 2018-06-21 |
| K180911 | Visura Technologies TEECAD System | Visura Technologies, LLC | FDS | Class II | 2018-06-20 |
| K181364 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | FEO | Class II | 2018-06-20 |
| K173316 | SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device | Transmed7, LLC | KNW | Class II | 2018-06-19 |
| K180738 | COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter | Compactcath, Inc. | EZD | Class II | 2018-06-14 |
| K172985 | Ligation Device | Leo Medical Co., Ltd. | FHN | Class II | 2018-06-14 |
| K180449 | Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. | FCG | Class II | 2018-06-08 |
| K172721 | FOCAL ONE | Edap Technomed, Inc. | PLP | Class II | 2018-06-07 |
| K172807 | Silicone Foley Catheter for single use | Changzhou Rongxin Medicine Minimal Invasion Technology | EZL | Class II | 2018-06-04 |
| K180800 | Colonic Plus Regular, Small, and Straight Shape Hydrokit | Colonic Plus | KPL | Class II | 2018-06-01 |
| K180026 | Bowel Management Device, Bowel Management Irrigation Set | Applied Medical Technology, Inc. | KNT | Class II | 2018-06-01 |
| K180325 | Single Use MultiClip Device | Micro-Tech (Nanjing) Co., Ltd. | PKL | Class II | 2018-06-01 |
| K173415 | EndoWrist 5mm Thoracic Grasper | Intuitive Surgical, Inc. | NAY | Class II | 2018-05-31 |
| K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | NAY | Class II | 2018-05-31 |
| K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100 | Fujifilm Corporation | FCX | Class II | 2018-05-25 |
| K180163 | TransEnterix Senhance Surgical System | Transenterix, Inc. | NAY | Class II | 2018-05-25 |
| K180111 | ClearGuard HD Antimicrobial Barrier Cap | Pursuit Vascular, Inc. | PEH | Class II | 2018-05-25 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.