Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 50
- Latest Decision
- 2018-05-24
Clearances · page 19 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K180807 | Celling Aspiration Needle | Spine Smith Holdings, LLC | KNW | Class II | 2018-05-24 |
| K180414 | EPX-4440FN Digital Video Processor with Light Source | Fujifilm New Development U.S.A., Inc. | FET | Class II | 2018-05-24 |
| K181108 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | FKX | Class II | 2018-05-24 |
| K180756 | Safety Wire Guide Introducer | Cook Incorporated | EZN | Class II | 2018-05-24 |
| K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords | Wilson-Cook Medical Inc./Cook Endoscopy | KNS | Class II | 2018-05-24 |
| K172729 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | FDI | Class II | 2018-05-21 |
| K173593 | staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | Class II | 2018-05-21 |
| K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes | Medical Components, Inc. (dba MedComp) | MSD | Class II | 2018-05-17 |
| K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) | Dimesol, Inc. | FIE | Class II | 2018-05-17 |
| K173758 | Disposable Biopsy Valve | Zhejiang Chuangxiang Medical Technology Co., Ltd. | OCX | Class II | 2018-05-14 |
| K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2018-05-10 |
| K173004 | SB Soft Hood - Straight type, SB Soft Hood - Undercut type | Sumitomo Bakelite Co., Ltd. | FDS | Class II | 2018-05-08 |
| K180214 | Repris Bladder Injection System | Uro-1, Inc. | FBK | Class II | 2018-05-03 |
| K180028 | Cook 810 Set, Desilets-Hoffman Introducer Set | Cook Incorporated | EZN | Class II | 2018-05-02 |
| K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets | Cook Incorporated | FGE | Class II | 2018-05-01 |
| K173718 | Liberty Cycler Set | Fresenius Medical Care Renal Therapies Group, LLC | FKX | Class II | 2018-05-01 |
| K180037 | Beacon EUS Access System | Covidien, LLC | FCG | Class II | 2018-04-26 |
| K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend | Intuitive Surgical, Inc. | NAY | Class II | 2018-04-26 |
| K173842 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | NAY | Class II | 2018-04-23 |
| K180102 | Embozene Color-Advanced Microspheres | Boston Scientific | NOY | Class II | 2018-04-19 |
| K172588 | Balloon Catheter and Balloon Ureteral Dilator Set | Cook Incorporated | EZN | Class II | 2018-04-19 |
| K180731 | Ultramatrix EUS Balloon | United States Endoscopy Group, Inc. (Us Endoscopy) | ODG | Class II | 2018-04-19 |
| K180836 | Genistrong | Genicon, Inc. | GCJ | Class II | 2018-04-18 |
| K173317 | DiLumen C2; DiLumen Tool Mount | Lumendi, LLC | FDF | Class II | 2018-04-17 |
| K172288 | Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy | KNS | Class II | 2018-04-17 |
| K172727 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | 2018-04-16 |
| K171603 | Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set | Cook Incorporated | FAD | Class II | 2018-04-16 |
| K180689 | Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device | STERIS Corporation | PKL | Class II | 2018-04-12 |
| K180530 | Imager II Urology Torque Catheter | Boston Scientific Corporation | KOD | Class II | 2018-04-10 |
| K180233 | Eviva Stereotactic Guided Breast Biopsy System | Hologic, Inc. | KNW | Class II | 2018-04-10 |
| K180208 | Disposable Endoscopic Trocar | Fengh Medical Co., Ltd. | GCJ | Class II | 2018-04-09 |
| K180033 | 8mm Monopolar Curved Scissors | Intuitive Surgical, Inc. | NAY | Class II | 2018-04-06 |
| K171857 | AMSure® Enteral Feeding Syringe with ENFit Tip | Amsino International, Inc. | PNR | Class II | 2018-03-30 |
| K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | MSB | Class II | 2018-03-30 |
| K171952 | Dimesol Tubing Sets for Hemodialysis | Dimesol, Inc. | FJK | Class II | 2018-03-30 |
| K172246 | OLYMPUS URF-V2/V2R | Olympus Medical Systems Corp. | FGB | Class II | 2018-03-30 |
| K173533 | Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter | Poiesis Medical, LLC | EZL | Class II | 2018-03-29 |
| K172298 | OLYMPUS URF-P6/P6R | Olympus Medical Systems Corp. | FGB | Class II | 2018-03-29 |
| K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket | Wilson-Cook Medical, Inc. | LQR | Class II | 2018-03-28 |
| K180114 | AEON Retrieval Bag | Lexington Medical, Inc. | GCJ | Class II | 2018-03-27 |
| K172017 | Black Silicone Filiform Double Pigtail Stent Set | Cook Incorporated | FAD | Class II | 2018-03-26 |
| K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter | Cook Incorporated | ODC | Class II | 2018-03-22 |
| K171973 | Captura® Disposable Hot Biopsy Forceps | Wilson-Cook Medical, Inc. | KGE | Class II | 2018-03-21 |
| K173919 | HX Device | Human Extension , Ltd. | GCJ | Class II | 2018-03-20 |
| K172762 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | PKL | Class II | 2018-03-20 |
| K171989 | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter | Wilson-Cook Medical, Inc. | ODD | Class II | 2018-03-20 |
| K180165 | Habib EndoHPB | Emcision , Ltd. | KNS | Class II | 2018-03-20 |
| K180579 | Ezee Retrieval | Genicon, Inc. | GCJ | Class II | 2018-03-19 |
| K171430 | Incontinence Treatment Device, Model LT2061 | Shenzhen Dongdixin Technology Co., Ltd. | KPI | Class II | 2018-03-15 |
| K180405 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | Fujifilm Corporation | FDF | Class II | 2018-03-15 |
| K173459 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | NEZ | Class II | 2018-03-13 |
| K173734 | RocaJJ Soft Stents | Promepla Sam | FAD | Class II | 2018-03-12 |
| K180450 | Corvocet Biopsy System | Merit Medical Systems, Inc. | KNW | Class II | 2018-03-12 |
| K180057 | VORTEK URETERAL DOUBLE LOOP STENT | Coloplast Corp. | FAD | Class II | 2018-03-09 |
| K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set | Cook Ireland, Ltd. | FGE | Class II | 2018-03-09 |
| K180135 | THD Anopress with THD SensyProbe | Thd Spa | KLA | Class II | 2018-03-08 |
| K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter | Gyrus Acmi, Inc. | FGE | Class II | 2018-03-08 |
| K180171 | PillCam Patency System | Given Imaging , Ltd. | NSI | Class II | 2018-03-08 |
| K172758 | Rotatable Snares, Non-Rotatable Snares | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FDI | Class II | 2018-03-07 |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Cook Incorporated | KOD | Class II | 2018-03-07 |
| K171939 | ALVUE Balloon Dilation System | Globus Medical, Inc. | GCJ | Class II | 2018-03-07 |
| K171750 | Citric Complete Dry Citric Acid (45X) | Dimesol USA, LLC | KPO | Class II | 2018-03-06 |
| K172663 | Cytology Brush | Micro-Tech (Nanjing) Co., Ltd. | FDX | Class II | 2018-03-05 |
| K172916 | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 | Fujifilm Corporation | FDS | Class II | 2018-03-01 |
| K171915 | Nathanson Transcystic Bile Duct Stone Exploration Pack | Cook Incorporated | LQR | Class II | 2018-03-01 |
| K180237 | Rezum System | Nxthera, Inc. | KNS | Class II | 2018-02-27 |
| K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S | Cook Ireland, Ltd. | FGE | Class II | 2018-02-27 |
| K171637 | OpClear System | Cipher Surgical, Ltd. | OCX | Class II | 2018-02-26 |
| K180327 | Stryker iVAS 13g Bone Biopsy Kit | Stryker Corporation | KNW | Class II | 2018-02-26 |
| K171671 | Prismaflex System 8.10 | Baxter Healthcare Corporation | KDI | Class II | 2018-02-23 |
| K172541 | Medline Catheter Specimen Collector | Medline Industries, Inc. | EZD | Class II | 2018-02-22 |
| K170683 | Aesculap Video Assisted Thoracic Surgery (VATS) INstruments | Aesculap, Inc. | GCJ | Class II | 2018-02-20 |
| K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated | KOD | Class II | 2018-02-16 |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | Class II | 2018-02-14 |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | OCW | Class II | 2018-02-12 |
| K172422 | Kohli Urinary Drainage Catheter | Nellie Medical, LLC | EZL | Class II | 2018-02-09 |
| K173400 | ORISE Tissue Retractor System | Boston Scientific | FED | Class II | 2018-02-09 |
| K173272 | Ergonomic Handle | Symmetry Surgical, Inc. | GCJ | Class II | 2018-02-09 |
| K173805 | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) | Marvao Medical Devices, Ltd. | MSD | Class II | 2018-02-08 |
| K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | Pentax Medical | FDT | Class II | 2018-02-07 |
| K171208 | Trans-anal Introducer | Visionsense, Ltd. | FED | Class II | 2018-02-05 |
| K180070 | SpeediCath Flex Coude Pro | Coloplast | GBM | Class II | 2018-02-02 |
| K172789 | Specimen Retrieval Bag | Beijing Hangtian Kadi Technology R&D Institute | GCJ | Class II | 2018-02-01 |
| K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter | Cook Incorporated | KOD | Class II | 2018-02-01 |
| K172643 | da Vinci Xi Surgical System; da Vinci X Surgical System | Intuitive Surgical, Inc. | NAY | Class II | 2018-01-31 |
| K170438 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | NEZ | Class II | 2018-01-30 |
| K171500 | Uro-V Cystoscope | Uroviu Corporation | FAJ | Class II | 2018-01-30 |
| K173596 | Rusch Intermittent Urethral Catheters | Teleflex Medical | EZC | Class II | 2018-01-29 |
| K173955 | Mic-Key* SF Over-the-Wire Stoma Measuring Device | Halyard Health, Inc. | KNT | Class II | 2018-01-26 |
| K173363 | Cycler Drain Bag Set | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | Class II | 2018-01-24 |
| K171673 | Focus Cap | Gce Medical Corporation | FDF | Class II | 2018-01-19 |
| K172575 | BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap | Baronova, Inc. | FED | Class II | 2018-01-18 |
| K173866 | Stryker AIM Light Source and SafeLight cable | Stryker | OWN | Class II | 2018-01-18 |
| K173559 | Barrx SB RFA Endoscopic Catheter | Covidien, LLC | KNS | Class II | 2018-01-18 |
| K163288 | Pelvifine Pelvic Muscle Trainer | Shenzhen Konmed Technology Co., Ltd. | KPI | Class II | 2018-01-18 |
| K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | Fujifilm Medical Systems U.S.A, Inc. | ODG | Class II | 2018-01-11 |
| K173234 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | FEO | Class II | 2018-01-10 |
| K173085 | invendoscopy E210 System | Invendo Medical GmbH | FDF | Class II | 2018-01-08 |
| K173650 | AquaShield System CO2- Fujifilm | United States Endoscopy Group, Inc. | FEQ | Class II | 2018-01-05 |
| K171099 | EON Portable Reverse Osmosis Water Purification System | Cantel | FIP | Class II | 2018-01-05 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.