meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
47
Latest Decision
2016-12-23

Clearances · page 22 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K163018 Zilver 635 Biliary Stent Cook Ireland, Ltd. FGE Class II 2016-12-23
K163068 pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent Q Urological Corporation FAD Class II 2016-12-22
K161467 HydraGuard 10 UltraFilter Nephros, Inc. NHV Class II 2016-12-22
K162128 Scope Buddy Plus Endoscope Flushing Aid Medivators, Inc. FEB Class II 2016-12-21
K160942 Sonablate Sonacare Medical, LLC PLP Class II 2016-12-21
K161844 Matrix Pre-Treatment Controller Better Water, LLC FIP Class II 2016-12-13
K162010 HPM-6000U BTL Industries, Inc. KPI Class II 2016-12-13
K162205 Arc EndoCuff and Arc EndoCuff Vision Boddingtons Plastics, Ltd. FED Class II 2016-12-09
K162428 DiLumen Endolumenal Interventional Platform Lumendi, LLC FDF Class II 2016-12-06
K163102 ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm Covidien GCJ Class II 2016-11-30
K163092 TubeClear Control Box and Clearing Stem Actuated Medical, Inc. KNT Class II 2016-11-30
K160801 Well Lead Extraction Bag Well Lead Medical Co., Ltd. GCJ Class II 2016-11-29
K160642 Medline ENFit Syringe Medline Industries, Inc. PIF Class II 2016-11-29
K153773 Disposal Lens Cleaning Sheath Olympus Medical Systems Corp. GCJ Class II 2016-11-22
K161277 ConvertX Nephroureteral Stent System Brightwater Medical FAD Class II 2016-11-22
K160855 U&U Enteral Syringe U&U Medical Technology Co, Ltd. PNR Class II 2016-11-22
K160558 RAPIDO HOLLOW-FIBRE DIALYZERS Bellco Srl KDI Class II 2016-11-18
K160881 Tablo Console Outset Medical, Inc. KDI Class II 2016-11-15
K162457 Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit Rocket Medical Plc PNG Class II 2016-11-14
K160437 PleurX Peritoneal Catheter System Care Fusion PNG Class II 2016-11-03
K160316 SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles M.D.L. S.R.L. KNW Class II 2016-10-27
K161720 Standard Clamp Standard Bariatrics GCJ Class II 2016-10-24
K161773 CapsoCam Plus (SV-3) Capsule Endoscope System CapsoVision, Inc. NEZ Class II 2016-10-21
K153784 NOSOGARD FILTERS Evoqua Water Technologies, LLC NHV Class II 2016-10-21
K160847 Rockwell Medical CitraPure Acid Concetrate Rockwell Medical KPO Class II 2016-10-20
K162445 LiVac Retractor System Livac Pty, Ltd. GCJ Class II 2016-10-20
K162622 Fujifilm Endoscope Models EC-600HL and EC-600LS Fujifilm Medical Systems U.S.A, Inc. FDF Class II 2016-10-18
K162584 VersaOne Bladeless Trocar Covidien GCJ Class II 2016-10-18
K161110 ClearPetra Suction-Evacuation Sheath Well Lead Medical Co., Ltd. FED Class II 2016-10-12
K153550 FTRD System Set Ovesco Endoscopy AG PKL Class II 2016-10-12
K162404 Express SD Biliary Monorail Premounted Stent System Boston Scientific Corporation FGE Class II 2016-10-12
K162059 EZEE RETRIEVAL Genicon, Inc. GCJ Class II 2016-09-29
K162332 Nexcore GI Insufflator Nexcore Technology, LLC FCX Class II 2016-09-29
K161672 SpeediCath Flex Coude Coloplast Corp. GBM Class II 2016-09-29
DEN150033 Sensor Monitored Alimentary Restriction Therapy (SMART) Device Scientific Intake ONY Class II 2016-09-26
K161838 Xenocor Xenoscope Laparoscopic System Xenocor, Inc. GCJ Class II 2016-09-26
K160015 Pure Vu Motus GI Medical Technologies , Ltd. FDF Class II 2016-09-22
K162188 Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) Vr Medical Technology PNR Class II 2016-09-22
K162411 da Vinci Xi 12 – 8 mm Reducer Intuitive Surgical, Inc. NAY Class II 2016-09-21
K162345 UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge Neotract, Inc. PEW Class II 2016-09-21
K161344 GentleCath Glide Intermittent Catheter Convatec Limited KOD Class II 2016-09-20
K161792 PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies, Inc. GCJ Class II 2016-09-20
K162110 CORGRIP NG/NI Tube Retention System Corpak Medsystems, Inc. A Division of Haylard Health KNT Class II 2016-09-15
K160117 AbClose - Port Site Closure Device Medeon Biodesign, Inc. OCW Class II 2016-09-09
K153542 Pelican Sling Retractor Beacon Surgical, Inc. GCJ Class II 2016-09-07
K160423 Perineologic Access Needle Corbin Clinical Resources, LLC FCG Class II 2016-09-02
K161963 Monoject Enteral Syringe with ENFit Connector Covidien PNR Class II 2016-09-01
K162152 Erbe’s CO2 Tubing/Cap Sets Erbe USA, Inc. FEQ Class II 2016-08-31
K160149 Miret Grasper, Alligator, Miret Grasper, Maryland Miret Surgical, Inc. OCW Class II 2016-08-30
K162119 UreTron PF Series Probe Med-Sonics Corp. FFK Class II 2016-08-29
K160797 FMX314 Surgical Platform Fortimedix Surgical B.V. OTJ Class II 2016-08-26
K161355 invendoscopy E200 System Invendo Medical GmbH FDF Class II 2016-08-25
K160766 Ambu USR, Ambu M Ambu A/S FAJ Class II 2016-08-17
K161445 PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C Adapta Medical, Inc. EZD Class II 2016-08-16
K161791 Aer-O-Scope Colonoscope System Gi View , Ltd. FDF Class II 2016-08-11
K162077 Laparoscopic Spray Applicator with Spinning Luers Micromedics, Inc. (D/B/A Nordson Medical) GCJ Class II 2016-08-11
K152834 Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 Colonplus Equipments & Speculums, S.L. KPL Class II 2016-08-10
K160787 Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet Syncro Medical Innovations, Inc. KNT Class II 2016-08-09
K161026 NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) Marvao Medical Devices, Ltd. MSD Class II 2016-08-09
K153709 Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet Devicor Medical Products, Inc. KNW Class II 2016-08-08
K153276 da Vinci Xi Surgical System Intuitive Surgical, Inc. NAY Class II 2016-08-07
K153329 MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis Med-Tech Water Systems, Inc. FIP Class II 2016-08-04
K161234 CASSI II Rotational Core Biopsy System Scion Medical Technologies, LLC KNW Class II 2016-08-03
K161409 M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem Mermaid Medical A/S KNW Class II 2016-08-02
K160275 Fuse Endoscopic System with FuseBox Processor Endochoice, Inc. PEA Class II 2016-08-01
K153205 IDSS ForceTriad Control Module Black Diamond Video, Inc. ODA Class II 2016-08-01
K152189 EVOTECH ECR Advanced Sterilization Products (Asp) FEB Class II 2016-07-20
K161805 EnCor MRI Introducer Set, EnCor Probe Introducer Senorx, Inc. KNW Class II 2016-07-19
K160846 AmplifEYE Medivators, Inc. FED Class II 2016-07-14
K161055 Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 Fuji Dynamics , Ltd. KPI Class II 2016-07-12
K161271 da Vinci Xi Surgical System Intuitive Surgical, Inc. NAY Class II 2016-07-11
K161247 Relizorb Alcresta Therapeutics, Inc. PLQ Class II 2016-06-30
K161186 Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) Fujifilm Medical Systems U.S.A, Inc. KGE Class II 2016-06-29
K151976 Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode Omnitech Systems, Inc. FAS Class II 2016-06-27
K161482 EndoChoice Water Bottle Cap Irrigation System Endochoice, Inc. FEQ Class II 2016-06-27
K160891 Ultrathane Endoureterotomy Stent Set Cook Incorporated FAD Class II 2016-06-24
K161421 Single Use Surgical Suction Irrigator Jiangsu Haize Medical Scientific Development Co., Ltd. GCJ Class II 2016-06-24
K152246 Aquarius Stoma Measuring Device Degania Silicone , Ltd. KNT Class II 2016-06-21
K160170 Lehman Manometry Catheter Wilson-Cook Medical, Inc. FFX Class II 2016-06-20
K152771 SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long Sumitomo Bakelite Co., Ltd. KNS Class II 2016-06-17
K161003 EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector Boston Scientific Corporation PIF Class II 2016-06-17
K161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) Neomed, Inc. PNR Class II 2016-06-17
K161045 Monoject Covidien PNR Class II 2016-06-17
K160795 United Urologics Intermittent Catheter Robling Medical GBM Class II 2016-06-16
K160625 Disposable Hot Biopsy Forceps Micro-Tech (Nanjing) Co., Ltd. KGE Class II 2016-06-14
K153434 Pall-Aquasafe Water Filter Pall International Sarl NHV Class II 2016-06-10
K161122 Sony IP Converter NU-IP40S Sony Electronics, Inc. GCJ Class II 2016-06-08
K161147 EndoCure Model EUR078A Endocure Technologies, Inc. FBN Class II 2016-06-07
DEN150040 WallFlex Biliary RX Fully Covered Stent System RMV Boston Scientific PNB Class II 2016-06-03
K153606 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application Smith & Nephew GCJ Class II 2016-06-02
K152583 KARL STORZ Endoscopic ICG Imaging System KARL STORZ Endoscopy-America, Inc. OWN Class II 2016-05-31
K161167 Seal Single-Use Biopsy Valve Endochoice, Inc. OCX Class II 2016-05-26
K160393 AdTec Aesculap, Inc. GCJ Class II 2016-05-26
K161228 Radiance Ultra Series ZeroWire Embedded Nds Surgical Imaging, LLC GCJ Class II 2016-05-26
K150956 PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies, Inc. GCJ Class II 2016-05-23
K160877 United Urologics Closed System Catheter Robling Medical, Inc. KOD Class II 2016-05-20
K160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes Mauna Kea Technologies OWN Class II 2016-05-20
K160403 SmartStart Air/Water and Suction Valves Endochoice, Inc. ODC Class II 2016-05-19
K153264 EasyPass Guidewire Medi-Globe Corporation OCY Class II 2016-05-19
K160332 Stryker SDC3 HD Information Management System with Wireless Device Control Capability Stryker Endoscopy GCJ Class II 2016-05-18

11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.