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
153d
Avg (2y)
1976
Since
2351 Gastroenterology & Urology devices
1751–1775 of 2351
Cleared Apr 25, 2003
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
K030975 · Baxter Healthcare Corp
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 28d
Cleared Apr 25, 2003
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
K030974 · Baxter Healthcare Corp
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 28d
Cleared Apr 17, 2003
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT
K030855 · Boston Scientific Corp
KNT · Tubes, Gastrointestinal (and Accessories) · 30d
Cleared Mar 25, 2003
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
K030645 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 25d
Cleared Mar 21, 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
K030107 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 67d
Cleared Mar 17, 2003
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
K030503 · Boston Scientific Corp
FAD · Stent, Ureteral · 26d
Cleared Mar 17, 2003
BARD AQUAGUIDE URETERAL CONDUIT
K030438 · C.R. Bard, Inc.
FED · Endoscopic Access Overtube, Gastroenterology-urology · 34d
Cleared Mar 10, 2003
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
K030409 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 31d
Cleared Feb 21, 2003
SYNTRA + DIALYZER, MODEL 200
K023664 · Baxter Healthcare Corp
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 113d
Cleared Jan 23, 2003
BARD ER URETERAL STENT WITH SUTURE
K022447 · C.R. Bard, Inc.
FAD · Stent, Ureteral · 181d
Cleared Jan 02, 2003
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
K021994 · C.R. Bard, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 198d
Cleared Dec 18, 2002
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
K023907 · Cordis Corp.
KNQ · Dilator, Esophageal · 23d
Cleared Dec 12, 2002
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM
K013562 · Baxter Healthcare Corp
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 412d
Cleared Nov 18, 2002
BAXTER ACCURA SYSTEM, MODEL 5M5660
K021615 · Baxter Healthcare Corp
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 186d
Cleared Oct 25, 2002
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K023217 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 161d
Cleared Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
K022135 · Boston Scientific Corp
KOD · Catheter, Urological · 74d
Cleared Sep 05, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
K022648 · Boston Scientific Corp
KNT · Tubes, Gastrointestinal (and Accessories) · 27d
Cleared Sep 03, 2002
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
K002612 · C.R. Bard, Inc.
EZL · Catheter, Retention Type, Balloon · 743d
Cleared Aug 23, 2002
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K022561 · C.R. Bard, Inc.
NFK · Kit, Repair, Catheter, Hemodialysis · 21d
Cleared Aug 14, 2002
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K021898 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 65d
Cleared Aug 08, 2002
URETERAL STENT
K013784 · Boston Scientific Corp
FAD · Stent, Ureteral · 267d
Cleared Aug 05, 2002
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K022434 · C.R. Bard, Inc.
MND · Ligator, Esophageal · 11d
Cleared Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
K020120 · Boston Scientific Corp
KNT · Tubes, Gastrointestinal (and Accessories) · 200d
Cleared Jul 09, 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
K014297 · Boston Scientific Corp
KNT · Tubes, Gastrointestinal (and Accessories) · 190d

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All categories 2351 FGE Stents, Drains And Dilators For The Biliary Ducts 155 KNT Tubes, Gastrointestinal (and Accessories) 110 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 74 FGB Ureteroscope And Accessories, Flexible/rigid 70 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 66 PKL Hemostatic Metal Clip For The Gi Tract 49 FED Endoscopic Access Overtube, Gastroenterology-urology 48 ODC Endoscope Channel Accessory 47 FAD Stent, Ureteral 45 OCX Endoscopic Irrigation/suction System 44 FAJ Cystoscope And Accessories, Flexible/rigid 44 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 FDF Colonoscope And Accessories, Flexible/rigid 39 KNW Instrument, Biopsy 39