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

9843
Total
9796
Cleared
154d
Avg (2y)
1976
Since
2599 Gastroenterology & Urology devices
1526–1550 of 2599
Cleared Feb 18, 2017
AXIOS Stent and Electrocautery Enhanced Delivery System
K163272 · Boston Scientific Corporation
PCU · Pancreatic Stent, Covered, Metallic, Removable · 89d
Cleared Jan 27, 2017
Universa Firm Ureteral Stents and Stent Sets
K161236 · Cook Incorporated
FAD · Stent, Ureteral · 270d
Cleared Jan 19, 2017
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K163069 · Olympus Medical Systems Corp.
NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule · 78d
Cleared Jan 06, 2017
Oracle EUS Balloon
K163492 · United States Endoscopy Group, Inc.
FDF · Colonoscope And Accessories, Flexible/rigid · 24d
Cleared Jan 06, 2017
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
K161504 · Cook Incorporated
MPB · Catheter, Hemodialysis, Non-implanted · 219d
Cleared Nov 29, 2016
Medline ENFit Syringe
K160642 · Medline Industries, Inc.
PIF · Gastrointestinal Tubes With Enteral Specific Connectors · 267d
Cleared Oct 12, 2016
Express SD Biliary Monorail Premounted Stent System
K162404 · Boston Scientific Corporation
FGE · Stents, Drains And Dilators For The Biliary Ducts · 44d
Cleared Jun 24, 2016
Ultrathane Endoureterotomy Stent Set
K160891 · Cook Incorporated
FAD · Stent, Ureteral · 85d
Cleared Jun 17, 2016
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
K161003 · Boston Scientific Corporation
PIF · Gastrointestinal Tubes With Enteral Specific Connectors · 67d
Cleared May 03, 2016
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K160845 · Boston Scientific Corporation
ODG · Endoscopic Ultrasound System, Gastroenterology-urology · 36d
Cleared Apr 04, 2016
Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
K151967 · Merit Medical Systems, Inc.
MSD · Catheter, Hemodialysis, Implanted · 263d
Cleared Mar 31, 2016
Proxis Ureteral Access Sheath
K160861 · C.R. Bard, Inc.
FED · Endoscopic Access Overtube, Gastroenterology-urology · 2d
Cleared Mar 30, 2016
Rotatable Snares
K160637 · Boston Scientific Corporation
FDI · Snare, Flexible · 23d
Cleared Mar 25, 2016
Corvocet Biopsy System
K153337 · Merit Medical Systems, Inc.
KNW · Instrument, Biopsy · 127d
Cleared Feb 09, 2016
Actreen Mini Intermittent Urinary Catheters
K151772 · B.Braun Medical, Inc.
GBM · Catheter, Urethral · 224d
Cleared Feb 04, 2016
Medline Anti-Fog Solution
K152948 · Medline Industries, Inc.
OCT · Anti Fog Solution And Accessories, Endoscopy · 121d
Cleared Feb 01, 2016
Image1 SPIES System
K160044 · KARL STORZ Endoscopy-America, Inc.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 24d
Cleared Jan 12, 2016
core nova Complete Operating Room Endoscopy
K151282 · Richard Wolf Medical Instruments Corp.
ODA · Endoscopic Central Control Unit · 243d
Cleared Jan 11, 2016
Universa Soft Ureteral Stents and Stent Sets
K151051 · Cook Incorporated
FAD · Stent, Ureteral · 266d
Cleared Jan 05, 2016
Zenysis Short-Term Dialysis Catheter
K153190 · C.R. Bard, Inc.
MPB · Catheter, Hemodialysis, Non-implanted · 63d
Cleared Dec 11, 2015
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
K153088 · Boston Scientific Corporation
PCU · Pancreatic Stent, Covered, Metallic, Removable · 46d
Cleared Nov 20, 2015
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
K152853 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 52d
Cleared Nov 13, 2015
LithoVue System
K153049 · Boston Scientific Corporation
FGB · Ureteroscope And Accessories, Flexible/rigid · 24d
Cleared Nov 06, 2015
Elation Wireguided Balloon Dilation Catheter
K151925 · Merit Medical Systems, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 116d
Cleared Oct 22, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151895 · Boston Scientific Corporation
FCG · Biopsy Needle · 104d

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All categories 2599 FGE Stents, Drains And Dilators For The Biliary Ducts 185 KNT Tubes, Gastrointestinal (and Accessories) 125 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 78 FGB Ureteroscope And Accessories, Flexible/rigid 71 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 70 PKL Hemostatic Metal Clip For The Gi Tract 50 FED Endoscopic Access Overtube, Gastroenterology-urology 48 FAD Stent, Ureteral 47 ODC Endoscope Channel Accessory 47 FAJ Cystoscope And Accessories, Flexible/rigid 46 OCX Endoscopic Irrigation/suction System 44 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 KNW Instrument, Biopsy 43 FDS Gastroscope And Accessories, Flexible/rigid 40