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

2376–2400 of 5370

Cleared Jul 01, 2003

GIVEN DIAGNOSTIC SYSTEM

K031033 · Given Imaging , Ltd.

NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule · 91d

Cleared Jun 30, 2003

RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM

K030559 · Rusch Intl.

ESW · Prosthesis, Esophageal · 129d

Cleared Jun 27, 2003

ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

K031538 · Boston Scientific Corp

KNT · Tubes, Gastrointestinal (and Accessories) · 42d

Cleared Jun 19, 2003

ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM

K031029 · Arthrocare Corp.

FAS · Electrode, Electrosurgical, Active, Urological · 79d

Cleared Jun 17, 2003

RUSCH GUIDED CHOLANGIOGRAPHY CATHETER

K023666 · Rusch Intl.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 229d

Cleared Jun 17, 2003

BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000

K030099 · Baxter Healthcare Corp

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 158d

Cleared Jun 16, 2003

HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER

K030020 · C.R. Bard, Inc.

MSD · Catheter, Hemodialysis, Implanted · 164d

Cleared Jun 16, 2003

MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K031197 · Cordis Corp.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 61d

Cleared May 30, 2003

FRESENIUS ULTRAFLUX HEMODIALYZER

K031378 · Fresenius Medical Care North America

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 29d

Cleared May 23, 2003

DEFLECTING URETERAL ACCESS SHEATH

K030642 · Applied Medical Resources Corp.

FED · Endoscopic Access Overtube, Gastroenterology-urology · 84d

Cleared May 23, 2003

AMSURE FOLEY INSERTION TRAY

K030664 · Amsino International, Inc.

FCM · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) · 81d

Cleared May 23, 2003

AMSURE URETHRAL CATHETERIZATION TRAY

K030712 · Amsino International, Inc.

FCM · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) · 78d

Cleared May 23, 2003

NAVIGATOR URETERAL ACCESS SHEATH SET

K030956 · Boston Scientific Corp

FED · Endoscopic Access Overtube, Gastroenterology-urology · 57d

Cleared May 22, 2003

AVITA BF1 (VITALIO) BODY FAT ANALYZER

K020738 · Avita Corporation

MNW · Analyzer, Body Composition · 442d

Cleared May 20, 2003

14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55

K030502 · Medcomp

MSD · Catheter, Hemodialysis, Implanted · 90d

Cleared May 15, 2003

BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM

K031295 · C.R. Bard, Inc.

PAG · Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 22d

Cleared May 09, 2003

DIATEK CANNON-CATHETER, MODEL CC5500

K022662 · Arrow Intl., Inc.

MSD · Catheter, Hemodialysis, Implanted · 273d

Cleared May 06, 2003

LUMINEXX ENDOSCOPIC BILIARY STENT

K031186 · C.R. Bard, Inc.

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

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 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 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 Apr 16, 2003

PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400

K030854 · E-Z-Em, Inc.

FCX · Insufflator, Automatic Carbon-dioxide For Endoscope · 29d

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

BARD AQUAGUIDE URETERAL CONDUIT

K030438 · C.R. Bard, Inc.

FED · Endoscopic Access Overtube, Gastroenterology-urology · 34d

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