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

9870

Total

9823

Cleared

154d

Avg (2y)

1976

Since

5370 Gastroenterology & Urology devices

2351–2375 of 5370

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 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 02, 2003

VAXCEL PLUS CHRONIC DIALYSIS CATHETER

K032712 · Boston Scientific Corp

MSD · Catheter, Hemodialysis, Implanted · 30d

Cleared Sep 29, 2003

K022490 · KARL STORZ Endoscopy-America, Inc.

GCT · Light Source, Endoscope, Xenon Arc · 427d

Cleared Sep 25, 2003

SENTINOL NITINOL BILLARY STENT SYSTEM

K032025 · Boston Scientific Corp

FGE · Stents, Drains And Dilators For The Biliary Ducts · 87d

Cleared Sep 23, 2003

KSEA OPSERVER LAP

K031895 · KARL STORZ Endoscopy-America, Inc.

FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 96d

Cleared Sep 17, 2003

PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K032137 · Cordis Corp.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 68d

Cleared Sep 15, 2003

PRISMA M60/M100 SETS

K032431 · Gambro, Inc.

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 40d

Cleared Sep 04, 2003

MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K032457 · Cordis Corp.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 24d

Cleared Aug 27, 2003

MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT

K032360 · Boston Scientific Corp

FGE · Stents, Drains And Dilators For The Biliary Ducts · 27d

Cleared Aug 21, 2003

LINVATEC 300W XENON LIGHT SOURCE

K031994 · Linvatec Corp.

GCT · Light Source, Endoscope, Xenon Arc · 55d

Cleared Aug 08, 2003

PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION

K032206 · Ev3, Inc.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 21d

Cleared Aug 06, 2003

SOFT-CELL DUAL LUMEN CATHETERS

K030277 · C.R. Bard, Inc.

MSD · Catheter, Hemodialysis, Implanted · 191d

Cleared Jul 30, 2003

NIAGARA TEMPORARY DUAL LUMEN CATHETERS

K030268 · C.R. Bard, Inc.

MPB · Catheter, Hemodialysis, Non-implanted · 184d

Cleared Jul 21, 2003

CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000

K030442 · C.R. Bard, Inc.

NFK · Kit, Repair, Catheter, Hemodialysis · 160d

Cleared Jul 18, 2003

MODIFICATION TO COOK ZILVER BILIARY STENT

K031821 · Cook, Inc.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 35d

Cleared Jul 17, 2003

MENTOR OBTAPE TRANS-OBTURATOR TAPE

K031767 · Mentor Corp.

OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 38d

Cleared Jul 14, 2003

ULTRAFLEX PRECISION COLONIC STENT

K030769 · Boston Scientific Corp

MQR · Stent, Colonic, Metallic, Expandable · 125d

Cleared Jul 11, 2003

COOK GASTRIC SIZING BALLOON CATHETER

K030841 · Cook, Inc.

KNT · Tubes, Gastrointestinal (and Accessories) · 116d

Cleared Jul 07, 2003

NXSTAGE SYSTEM ONE

K030470 · Nxstage Medical, Inc.

FII · System, Dialysate Delivery, Sealed · 145d

Cleared Jul 07, 2003

MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K031777 · Cordis Corp.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 27d

Cleared Jul 03, 2003

EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM

K024303 · Edwards Lifesciences, LLC

FGE · Stents, Drains And Dilators For The Biliary Ducts · 191d

Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.

Search all Gastroenterology & Urology 510(k) devices