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

8424 Gastroenterology & Urology devices

3726–3750 of 8424

Cleared Sep 02, 2003

ENDOSCOPIC LIGHT SOURCE LS-3000X

K032545 · Mgb Endoskopische Gerate GmbH (Berlin)

FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 15d

Cleared Aug 27, 2003

VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES

K031748 · Vitalcare Group, Inc.

EZL · Catheter, Retention Type, Balloon · 83d

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 26, 2003

K022721 · W.O.M. World of Medicine AG

EXY · Uroflowmeter · 375d

Cleared Aug 21, 2003

LINVATEC 300W XENON LIGHT SOURCE

K031994 · Linvatec Corp.

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

Cleared Aug 20, 2003

SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE

K023902 · Usgi Medical, Inc.

FED · Endoscopic Access Overtube, Gastroenterology-urology · 271d

Cleared Aug 20, 2003

DESIGNS FOR VISION FIBEROPTIC LIGHT

K032283 · Designs For Vision, Inc.

GDB · Endoscope, Fiber Optic · 27d

Cleared Aug 14, 2003

MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K021560 · Ameriwater

FIP · Subsystem, Water Purification · 458d

Cleared Aug 12, 2003

WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM

K031331 · Abbott Vascular, Inc.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 106d

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

NANMA ADJUSTABLE CONSTRICTION RING

K030119 · Nanma Mfg Co., Ltd.

LKY · Device, External Penile Rigidity · 205d

Cleared Aug 06, 2003

SOFT-CELL DUAL LUMEN CATHETERS

K030277 · C.R. Bard, Inc.

MSD · Catheter, Hemodialysis, Implanted · 191d

Cleared Aug 01, 2003

WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20

K031582 · Nihon Seimitsu Sokki Co., Ltd.

MNW · Analyzer, Body Composition · 72d

Cleared Jul 31, 2003

LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)

K021362 · Organ Recovery Systems, Inc.

KDN · System, Perfusion, Kidney · 457d

Cleared Jul 30, 2003

NIAGARA TEMPORARY DUAL LUMEN CATHETERS

K030268 · C.R. Bard, Inc.

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

Cleared Jul 28, 2003

REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500

K030170 · Opus Medical, Inc.

OCW · Endoscopic Tissue Approximation Device · 192d

Cleared Jul 23, 2003

XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE

K031256 · Olympus Opto-Electronics Co., Ltd.

FDA · Enteroscope And Accessories · 93d

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 16, 2003

ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE

K030960 · Acmi Corporation

FAJ · Cystoscope And Accessories, Flexible/rigid · 111d

Cleared Jul 16, 2003

OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE

K032092 · Olympus Optical Co., Ltd.

FCL · Forceps, Biopsy, Non-electric · 9d

Cleared Jul 14, 2003

ULTRAFLEX PRECISION COLONIC STENT

K030769 · Boston Scientific Corp

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

Cleared Jul 11, 2003

K030456 · Vasc-Alert, LLC

KOC · Accessories, Blood Circuit, Hemodialysis · 150d

Cleared Jul 11, 2003

COOK GASTRIC SIZING BALLOON CATHETER

K030841 · Cook, Inc.

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

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

Search all Gastroenterology & Urology 510(k) devices