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

8427 Gastroenterology & Urology devices

3876–3900 of 8427

Cleared Dec 20, 2002

FLEXIMA BILIARY CATHETER

K023870 · Boston Scientific/Medi-Tech

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

Cleared Dec 20, 2002

XTJF-160AF DUODENOVIDEOSCOPE

K024033 · Olympus Optical Co., Ltd.

FDT · Duodenoscope And Accessories, Flexible/rigid · 14d

Cleared Dec 19, 2002

VIABIL BILIARY ENDOPROSTHESIS

K014215 · W.L. Gore & Associates, Inc.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 363d

Cleared Dec 19, 2002

SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES

K024011 · Surgical Instruments Service and Savings, Inc.

NLU · Forceps, Biopsy, Electric, Reprocessed · 15d

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 13, 2002

LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER

K022905 · Horizon Medical Products, Inc.

MSD · Catheter, Hemodialysis, Implanted · 101d

Cleared Dec 13, 2002

MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY

K023243 · Sulzer Intratherapeutics, Inc.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 74d

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 Dec 11, 2002

NXSTAGE CARTRIDGE EXPRESS

K014152 · Nxstage Medical, Inc.

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 358d

Cleared Dec 11, 2002

SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE

K023923 · Senorx, Inc.

KNW · Instrument, Biopsy · 16d

Cleared Dec 10, 2002

VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000

K023019 · Vomed Volzer Medizintechnik GmbH & Co.

FGI · Catheter, Urethrographic, Male · 90d

Cleared Dec 04, 2002

TRANSONIC SYRINGE WARMER, MODEL SYR-1000

K022963 · Transonic Systems, Inc.

MQS · System, Hemodialysis, Access Recirculation Monitoring · 89d

Cleared Nov 25, 2002

LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE

K022686 · Lap Surgical Systems, LLC

FED · Endoscopic Access Overtube, Gastroenterology-urology · 104d

Cleared Nov 21, 2002

POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151

K014269 · Medtronic Functional Diagnostics A/S

MYE · System, Electrogastrography (egg) · 329d

Cleared Nov 19, 2002

MONARC SLING SYSTEM

K023516 · American Medical Systems, Inc.

OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 29d

Cleared Nov 18, 2002

RENAX HEMODIALYSIS BLOOD TUBING SET

K014140 · Sunder Biomedical Tech. Co., Ltd.

FJK · Set, Tubing, Blood, With And Without Anti-regurgitation Valve · 336d

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 Nov 13, 2002

FRESENIUS ICARE MONITORING SYSTEM

K021060 · Fresenius Medical Care North America

FKP · System, Dialysate Delivery, Single Patient · 225d

Cleared Nov 08, 2002

BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER

K011471 · Medtronic Functional Diagnostics A/S

FFX · System, Gastrointestinal Motility (electrical) · 543d

Cleared Nov 06, 2002

RETRO REPAIR KIT, MODEL PRRK5

K022644 · Spire Biomedical, Inc.

NFK · Kit, Repair, Catheter, Hemodialysis · 90d

Cleared Nov 06, 2002

INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE

K023344 · Bowel Management Systems, LLC

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

Cleared Nov 04, 2002

DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION

K021732 · Dideco S.P.A.

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 164d

Cleared Nov 04, 2002

REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS

K022751 · Medical Device Services

KGE · Forceps, Biopsy, Electric · 77d

Cleared Nov 01, 2002

PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS

K011005 · Pure Water Solutions, Inc.

FIP · Subsystem, Water Purification · 576d

Cleared Oct 31, 2002

MEDCOMP REPAIR KIT, MODEL ASPCRPK

K022570 · Medcomp

NFK · Kit, Repair, Catheter, Hemodialysis · 90d

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