FDA Review Panel · GU

FDA 510(k) Gastroenterology & Urology Devices

FDA 510(k) Gastroenterology & Urology Devices - Regulatory Overview

FDA 510(k) gastroenterology and urology devices cover diagnostic and interventional equipment for the GI tract and urinary system. The FDA review panel code is GU.

Common device types:

  • GI endoscopes - gastroscopes, colonoscopes, duodenoscopes and capsule endoscopy
  • Biliary and pancreatic stents - metal and plastic biliary drainage devices
  • Urological devices - ureteral stents, catheters, stone retrieval baskets
  • Ablation systems - RFA and cryoablation for GI lesions
  • Anorectal devices - manometry systems, hemorrhoid treatment

9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5365 Gastroenterology & Urology devices
1426–1450 of 5365
Cleared Apr 10, 2018
Imager II Urology Torque Catheter
K180530 · Boston Scientific Corporation
KOD · Catheter, Urological · 41d
Cleared Apr 10, 2018
Eviva Stereotactic Guided Breast Biopsy System
K180233 · Hologic, Inc.
KNW · Instrument, Biopsy · 71d
Cleared Apr 04, 2018
leva Pelvic Floor Trainer
K180637 · Renovia, Inc.
HIR · Perineometer · 23d
Cleared Mar 30, 2018
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
K180194 · Paragonix Technologies, Inc.
MSB · System And Accessories, Isolated Heart, Transport And Preservation · 65d
Cleared Mar 30, 2018
OLYMPUS URF-V2/V2R
K172246 · Olympus Medical Systems Corp.
FGB · Ureteroscope And Accessories, Flexible/rigid · 247d
Cleared Mar 30, 2018
Dimesol Tubing Sets for Hemodialysis
K171952 · Dimesol, Inc.
FJK · Set, Tubing, Blood, With And Without Anti-regurgitation Valve · 274d
Cleared Mar 30, 2018
AMSure® Enteral Feeding Syringe with ENFit Tip
K171857 · Amsino International, Inc.
PNR · Enteral Syringes With Enteral Specific Connectors · 282d
Cleared Mar 29, 2018
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
K173533 · Poiesis Medical, LLC
EZL · Catheter, Retention Type, Balloon · 134d
Cleared Mar 29, 2018
OLYMPUS URF-P6/P6R
K172298 · Olympus Medical Systems Corp.
FGB · Ureteroscope And Accessories, Flexible/rigid · 241d
Cleared Mar 28, 2018
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
K171969 · Wilson-Cook Medical, Inc.
LQR · Dislodger, Stone, Biliary · 271d
Cleared Mar 26, 2018
Black Silicone Filiform Double Pigtail Stent Set
K172017 · Cook Incorporated
FAD · Stent, Ureteral · 266d
Cleared Mar 22, 2018
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
K173105 · Cook Incorporated
ODC · Endoscope Channel Accessory · 174d
Cleared Mar 21, 2018
Captura® Disposable Hot Biopsy Forceps
K171973 · Wilson-Cook Medical, Inc.
KGE · Forceps, Biopsy, Electric · 264d
Cleared Mar 20, 2018
Habib EndoHPB
K180165 · Emcision , Ltd.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 57d
Cleared Mar 20, 2018
Single Use Hemoclip
K172762 · Zhejiang Chuangxiang Medical Technology Co., Ltd.
PKL · Hemostatic Metal Clip For The Gi Tract · 188d
Cleared Mar 20, 2018
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
K171989 · Wilson-Cook Medical, Inc.
ODD · Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula · 260d
Cleared Mar 15, 2018
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K180405 · Fujifilm Corporation
FDF · Colonoscope And Accessories, Flexible/rigid · 29d
Cleared Mar 15, 2018
Incontinence Treatment Device, Model LT2061
K171430 · Shenzhen Dongdixin Technology Co., Ltd.
KPI · Stimulator, Electrical, Non-implantable, For Incontinence · 304d
Cleared Mar 13, 2018
Olympus Small Intestinal Capsule Endoscope System
K173459 · Olympus Medical Systems Corp.
NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule · 126d
Cleared Mar 12, 2018
Corvocet Biopsy System
K180450 · Merit Medical Systems, Inc.
KNW · Instrument, Biopsy · 20d
Cleared Mar 12, 2018
RocaJJ Soft Stents
K173734 · Promepla Sam
FAD · Stent, Ureteral · 96d
Cleared Mar 09, 2018
VORTEK URETERAL DOUBLE LOOP STENT
K180057 · Coloplast Corp.
FAD · Stent, Ureteral · 60d
Cleared Mar 09, 2018
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
K172057 · Cook Ireland, Ltd.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 246d
Cleared Mar 08, 2018
PillCam Patency System
K180171 · Given Imaging , Ltd.
NSI · System, Imaging, Esophageal, Wireless, Capsule · 45d
Cleared Mar 08, 2018
THD Anopress with THD SensyProbe
K180135 · Thd Spa
KLA · Monitor, Esophageal Motility, Anorectal Motility, And Tube · 50d

Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.

Search all Gastroenterology & Urology 510(k) devices

Filter by Product Code

All categories 5365 FGE Stents, Drains And Dilators For The Biliary Ducts 314 KNT Tubes, Gastrointestinal (and Accessories) 301 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 217 KOD Catheter, Urological 128 KNW Instrument, Biopsy 122 KOC Accessories, Blood Circuit, Hemodialysis 121 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 116 FJI Dialyzer, Capillary, Hollow Fiber 96 FAD Stent, Ureteral 94 KDJ Set, Administration, For Peritoneal Dialysis, Disposable 91 FGB Ureteroscope And Accessories, Flexible/rigid 89 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 81 FDF Colonoscope And Accessories, Flexible/rigid 71 EXB Collector, Ostomy 68 FED Endoscopic Access Overtube, Gastroenterology-urology 67