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
8423 Gastroenterology & Urology devices
3676–3700 of 8423
Cleared Nov 17, 2003
STONE EXTRACTOR BALLOON CATHETER
K011261 · Medi-Globe Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 936d
Cleared Nov 17, 2003
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
K033134 · Ev3, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 48d
Cleared Nov 14, 2003
AUTO-BAND LIGATOR
K031236 · Scandimed. A.S.
MND · Ligator, Esophageal · 210d
Cleared Nov 14, 2003
BARD DUAL LUMEN URETERAL CATHETER
K032521 · C.R. Bard, Inc.
EYB · Catheter, Ureteral, Gastro-urology · 91d
Cleared Nov 14, 2003
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
K033333 · Aomori Olympus Co., Ltd.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Nov 10, 2003
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
K033393 · Guidant Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 18d
Cleared Nov 10, 2003
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K033427 · Neothermia Corp.
KNW · Instrument, Biopsy · 13d
Cleared Nov 06, 2003
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K033245 · C.R. Bard, Inc.
MND · Ligator, Esophageal · 30d
Cleared Oct 30, 2003
DBB-05 HEMODIALYSIS DELIVERY SYSTEM
K023509 · Davita Clinical Research (Trri)
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 377d
Cleared Oct 30, 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS
K033212 · Orbus Medical Technologies
FGE · Stents, Drains And Dilators For The Biliary Ducts · 27d
Cleared Oct 29, 2003
AMSURE FOLEY CATHETER
K030120 · Amsino International, Inc.
EZL · Catheter, Retention Type, Balloon · 289d
Cleared Oct 29, 2003
GIVEN DIAGNOSTIC SYSTEM
K032405 · Given Imaging , Ltd.
NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule · 86d
Cleared Oct 29, 2003
MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
K033126 · Behavioral Technology, Inc.
LIL · Monitor, Penile Tumescence · 29d
Cleared Oct 28, 2003
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
K032356 · Nxstage Medical, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 90d
Cleared Oct 27, 2003
PERFADEX SOLUTION FOR LUNG PRESERVATION
K022730 · Vitrolife AB
MSB · System And Accessories, Isolated Heart, Transport And Preservation · 437d
Cleared Oct 23, 2003
MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
K032530 · Guidant Corporation
FGE · Stents, Drains And Dilators For The Biliary Ducts · 69d
Cleared Oct 23, 2003
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
K032820 · Ndo Surgical, Inc.
ODE · Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) · 43d
Cleared Oct 23, 2003
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K032930 · Boston Scientific Corp
ESW · Prosthesis, Esophageal · 31d
Cleared Oct 22, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K032580 · Ev3, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 62d
Cleared Oct 22, 2003
MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822
K032929 · Abbott Vascular, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Oct 21, 2003
BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE
K030348 · Biolab Equipment Canada , Ltd.
FIP · Subsystem, Water Purification · 260d
Cleared Oct 16, 2003
STRYKER FLEXIBLE URETEROSCOPE
K031278 · Stryker Endoscopy
FGB · Ureteroscope And Accessories, Flexible/rigid · 177d
Cleared Oct 09, 2003
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · Ethicon Endo-Surgery, Inc.
KNW · Instrument, Biopsy · 239d
Cleared Oct 09, 2003
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
K032138 · Medtronic Vascular
KLA · Monitor, Esophageal Motility, Anorectal Motility, And Tube · 90d
Cleared Oct 09, 2003
SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM
K032506 · Sanarus Medical, Inc.
KNW · Instrument, Biopsy · 56d

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All categories 8423 KNT Tubes, Gastrointestinal (and Accessories) 525 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 106 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 104