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

9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8414 Gastroenterology & Urology devices
2951–2975 of 8414
Cleared Aug 22, 2008
OHMNISCAN NG
K073334 · Christine Valmy, Inc.
MNW · Analyzer, Body Composition · 268d
Cleared Aug 18, 2008
ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
K072708 · Abbott Vascular-Vascular Solutions
FGE · Stents, Drains And Dilators For The Biliary Ducts · 328d
Cleared Aug 11, 2008
IEC MEDSIGHT AND MEDBRIGHT
K080809 · Innovative Endoscopy Components, LLC
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 143d
Cleared Aug 08, 2008
MAPERSOL
K080432 · Preservation Solutions, Inc.
KDN · System, Perfusion, Kidney · 171d
Cleared Aug 06, 2008
FOSSA URETERAL OPEN STENTS
K072293 · Fossa Medical, Inc.
FAD · Stent, Ureteral · 356d
Cleared Aug 01, 2008
MODIFICATION TO ZILVER 635 BILIARY STENT
K080037 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 207d
Cleared Jul 30, 2008
ANCHORAGE SCOPE, MODEL 000003
K080780 · Epitek, Inc.
FBO · Cystourethroscope · 133d
Cleared Jul 22, 2008
GORE VIABIL BILILARY ENDOPROSTHESIS
K081184 · W.L. Gore & Associates, Inc. Medical Products Div.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 88d
Cleared Jul 22, 2008
BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
K081323 · B-K Medical Aps
FCG · Biopsy Needle · 71d
Cleared Jul 18, 2008
BLOOD TUBING SETS (STERILE FLUID PATH)
K080807 · Nxstage Medical, Inc.
FJK · Set, Tubing, Blood, With And Without Anti-regurgitation Valve · 119d
Cleared Jul 18, 2008
ASPIRA PERITONEAL DRAINAGE SYSTEM
K081288 · C.R. Bard, Inc.
PNG · Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling · 72d
Cleared Jul 17, 2008
MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
K080878 · Medical Technologies of Georgia, Inc.
KOD · Catheter, Urological · 108d
Cleared Jul 07, 2008
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
K081043 · Nxstage Medical, Inc.
KOC · Accessories, Blood Circuit, Hemodialysis · 84d
Cleared Jul 03, 2008
COSTORSOL
K073693 · Preservation Solutions, Inc.
KDN · System, Perfusion, Kidney · 185d
Cleared Jun 27, 2008
ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
K073644 · Endogastric Solutions, Inc.
OCW · Endoscopic Tissue Approximation Device · 184d
Cleared Jun 27, 2008
MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
K080679 · Viasys Medsystems
KNT · Tubes, Gastrointestinal (and Accessories) · 109d
Cleared Jun 20, 2008
ENDOSCOPY VIDEO CAMERA SYSTEM
K081585 · Vision Systems Group, A Division of Viking Systems
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 15d
Cleared Jun 18, 2008
LUXTEC MLX LIGHT SOURCE
K081477 · Integra Luxtec, Inc.
FCW · Light Source, Fiberoptic, Routine · 22d
Cleared Jun 17, 2008
INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
K081057 · Intact Medical Corporation
KNW · Instrument, Biopsy · 64d
Cleared Jun 13, 2008
BARD DIGNICARE STOOL MANAGEMENT SYSTEM
K073598 · C.R. Bard, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 175d
Cleared Jun 13, 2008
PRISMAFLEX M150 SET
K080519 · Gambro Renal Products, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 109d
Cleared Jun 12, 2008
ETHICON ENDO SURGERY ARTICULATING SNARE
K073288 · Ethicon Endo-Surgery, Inc.
FDI · Snare, Flexible · 204d
Cleared Jun 11, 2008
CURE CATHETER CLOSED SYSTEM
K080881 · Cure Medical, LLC
KOD · Catheter, Urological · 72d
Cleared Jun 10, 2008
MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
K080550 · Minos Medical
ODB · Endoscopic Contamination Prevention Sheath · 103d
Cleared Jun 02, 2008
BTI FILTRATION DEIONIZATION EXCHANGE TANK
K080703 · 4m Ventures, Inc.
FIP · Subsystem, Water Purification · 82d

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All categories 8414 KNT Tubes, Gastrointestinal (and Accessories) 524 FGE Stents, Drains And Dilators For The Biliary Ducts 461 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 331 KNW Instrument, Biopsy 280 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 168 KOD Catheter, Urological 164 KOC Accessories, Blood Circuit, Hemodialysis 145 MSD Catheter, Hemodialysis, Implanted 124 EZL Catheter, Retention Type, Balloon 119 FJI Dialyzer, Capillary, Hollow Fiber 119 FAD Stent, Ureteral 113 FGB Ureteroscope And Accessories, Flexible/rigid 112 FDF Colonoscope And Accessories, Flexible/rigid 111 FIP Subsystem, Water Purification 105 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 104