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

8423 Gastroenterology & Urology devices

3651–3675 of 8423

Cleared Dec 30, 2003

MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT

K033778 · C.R. Bard, Inc.

FED · Endoscopic Access Overtube, Gastroenterology-urology · 26d

Cleared Dec 23, 2003

STERICHEK BICARB PH REAGENT STRIPS

K031267 · Environmental Test Systems, Inc.

MNV · Strip, Dialysate Ph Indicator · 246d

Cleared Dec 23, 2003

DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

K031689 · Chf Solutions, Inc.

NQJ · Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use · 204d

Cleared Dec 23, 2003

DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH

K032061 · Spire Biomedical, Inc.

MSD · Catheter, Hemodialysis, Implanted · 173d

Cleared Dec 23, 2003

INTERMITTENT URETHRAL CATHETERS

K033023 · Rusch Intl.

KOD · Catheter, Urological · 88d

Cleared Dec 23, 2003

IRRIGATION CHANNEL TUBING, MODEL 100135

K033695 · Byrne Medical, Inc.

OCX · Endoscopic Irrigation/suction System · 28d

Cleared Dec 22, 2003

CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM

K033394 · Cordis Corp.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 60d

Cleared Dec 19, 2003

WILSON-COOK TRI-TOME SELECT PLUS

K033203 · Wilson-Cook Medical, Inc.

KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 78d

Cleared Dec 19, 2003

SAFYRE VS AND SAFYRE T

K033691 · Promedon

OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 25d

Cleared Dec 17, 2003

STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS

K032943 · Stryker Corp.

KNW · Instrument, Biopsy · 86d

Cleared Dec 15, 2003

ZILVER 518 BILIARY STENT

K033348 · Cook, Inc.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 56d

Cleared Dec 12, 2003

MOTILITY VISUALIZATION SYSTEM

K031169 · Sierra Scientific Instruments, Inc.

FFX · System, Gastrointestinal Motility (electrical) · 242d

Cleared Dec 12, 2003

FASTRAC GASTRIC ACCESS PORT KIT

K033562 · C.R. Bard, Inc.

KNT · Tubes, Gastrointestinal (and Accessories) · 30d

Cleared Dec 10, 2003

SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005

K033537 · Abbott Laboratories

FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d

Cleared Dec 08, 2003

GYNECARE TVT OBTURATOR SYSTEM

K033568 · Ethicon, Inc.

OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 26d

Cleared Dec 04, 2003

LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA

K023023 · Vasca, Inc.

MSD · Catheter, Hemodialysis, Implanted · 449d

Cleared Dec 03, 2003

K032988 · Danmeter A/S

KPI · Stimulator, Electrical, Non-implantable, For Incontinence · 70d

Cleared Nov 26, 2003

HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT

K033294 · C.R. Bard, Inc.

MSD · Catheter, Hemodialysis, Implanted · 43d

Cleared Nov 26, 2003

FOSSA URETERAL OPEN LUMEN STENT

K033368 · Fossa Medical, Inc.

EYB · Catheter, Ureteral, Gastro-urology · 36d

Cleared Nov 26, 2003

NXSTAGE PUREFLOW SOLUTION

K033386 · Nxstage Medical, Inc.

KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 34d

Cleared Nov 25, 2003

LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS

K033335 · Siemens Medical Solutions USA, Inc.

MMZ · Table, Cystometric, Electric · 40d

Cleared Nov 21, 2003

PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM

K033314 · Ev3, Inc.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 37d

Cleared Nov 20, 2003

SYSTEM 100 ULTRAFILTRATION CATHETER

K023874 · Chf Solutions, Inc.

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 364d

Cleared Nov 20, 2003

HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q

K031676 · Baxter Healthcare Corp

KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 174d

Cleared Nov 20, 2003

REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS

K033593 · Clearmedical, Inc.

NLU · Forceps, Biopsy, Electric, Reprocessed · 7d

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