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
2641 Gastroenterology & Urology devices
1901–1925 of 2641
Cleared Jan 07, 2000
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
K994156 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Jan 06, 2000
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
K993892 · C.R. Bard, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 51d
Cleared Jan 06, 2000
BARD MEMOTHERM FLEXX BILIARY STENT
K993392 · C.R. Bard, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 90d
Cleared Dec 23, 1999
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K994068 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 21d
Cleared Dec 10, 1999
BARDEX I.C. PEDIATRIC FOLEY CATHETER
K993464 · C.R. Bard, Inc.
MJC · Catheter, Urological (antimicrobial) And Accessories · 58d
Cleared Dec 10, 1999
ENDOSCOPES,10MM DIAMETER 0 DEGREES
K993103 · Richard Wolf Medical Instruments Corp.
GCM · Endoscope, Rigid · 85d
Cleared Nov 28, 1999
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K993646 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Nov 24, 1999
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K992894 · Baxter Healthcare Corp
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 89d
Cleared Nov 03, 1999
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
K991672 · Olympus America, Inc.
FCG · Biopsy Needle · 170d
Cleared Oct 29, 1999
PALMAZ XL TANSHEPATIC BILIARY STENTS
K993091 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 43d
Cleared Sep 17, 1999
OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
K984358 · Olympus America, Inc.
FDS · Gastroscope And Accessories, Flexible/rigid · 284d
Cleared Sep 10, 1999
BARD BALLOON INFLATION SYSTEM
K991375 · C.R. Bard, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 142d
Cleared Aug 12, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
K991674 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 87d
Cleared Aug 04, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
K991028 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 128d
Cleared Jul 12, 1999
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
K982326 · Boston Scientific Corp
MSD · Catheter, Hemodialysis, Implanted · 375d
Cleared Jul 06, 1999
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
K991323 · Smith & Nephew, Inc.
FFS · Image, Illumination, Fiberoptic, For Endoscope · 78d
Cleared Jun 22, 1999
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
K991056 · Boston Scientific Corp
MQR · Stent, Colonic, Metallic, Expandable · 84d
Cleared Jun 18, 1999
RENAL LINK
K990953 · Baxter Healthcare Corp
KPF · System, Dialysate Delivery, Semi-automatic, Peritoneal · 88d
Cleared Jun 11, 1999
FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253
K991178 · Richard Wolf Medical Instruments Corp.
FGB · Ureteroscope And Accessories, Flexible/rigid · 65d
Cleared Jun 11, 1999
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K990864 · Boston Scientific Corp
MND · Ligator, Esophageal · 87d
Cleared Jun 04, 1999
AUTO SUTURE ABBI SYSTEM
K983296 · United States Surgical, A Division of Tyco Healthc
KNW · Instrument, Biopsy · 256d
Cleared Apr 30, 1999
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
K990631 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 63d
Cleared Apr 30, 1999
HP M2376A DEVICE LINK SYSTEM
K984194 · Hewlett-Packard Co.
MQS · System, Hemodialysis, Access Recirculation Monitoring · 158d
Cleared Mar 26, 1999
URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042
K990050 · Richard Wolf Medical Instruments Corp.
FGB · Ureteroscope And Accessories, Flexible/rigid · 78d
Cleared Mar 22, 1999
KSEA ENDOSCOPE HOLDER
K990334 · KARL STORZ Endoscopy-America, Inc.
OCV · Endoscope Holder · 47d

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 2641 FGE Stents, Drains And Dilators For The Biliary Ducts 188 KNT Tubes, Gastrointestinal (and Accessories) 125 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 78 FGB Ureteroscope And Accessories, Flexible/rigid 74 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 71 PKL Hemostatic Metal Clip For The Gi Tract 50 FED Endoscopic Access Overtube, Gastroenterology-urology 49 FAD Stent, Ureteral 47 ODC Endoscope Channel Accessory 47 FAJ Cystoscope And Accessories, Flexible/rigid 47 OCX Endoscopic Irrigation/suction System 44 KNW Instrument, Biopsy 44 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 FDS Gastroscope And Accessories, Flexible/rigid 41