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

9843
Total
9796
Cleared
153d
Avg (2y)
1976
Since
2373 Gastroenterology & Urology devices
2276–2300 of 2373
Cleared Mar 02, 1982
CAPD U.V. GERMICIDAL CONNECTION SYSTEM
K812802 · Travenol Laboratories, S.A.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 147d
Cleared Nov 17, 1981
WOUND DRAINAGE MANAGEMENT SYSTEMS
K813080 · Howmedica Corp.
EXB · Collector, Ostomy · 15d
Cleared Nov 10, 1981
PRE-FILLED SYRINGE & CYSTOFLO URINARY BG
K811924 · Travenol Laboratories, S.A.
KOD · Catheter, Urological · 131d
Cleared Sep 21, 1981
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K811830 · Cordis Corp.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 84d
Cleared Sep 08, 1981
UROFLOWMETER
K811925 · C.R. Bard, Inc.
FFG · Device, Urine Flow Rate Measuring, Non-electrical, Disposable · 68d
Cleared Jul 31, 1981
CORDIS DOW SERA FLO TM TRANSDUCER PROT
K811892 · Cordis Corp.
FIB · Protector, Transducer, Dialysis · 30d
Cleared Jun 02, 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726 · Howmedica Corp.
EXB · Collector, Ostomy · 77d
Cleared May 21, 1981
VASOVASOSTOMY STABILIZER PLATFORM DEV
K811223 · Biomet, Inc.
KOA · Surgical Instruments, G-u, Manual (and Accessories) · 17d
Cleared Apr 29, 1981
ENTERNAL PUMP SET W/INTEGRAL CONTAINER
K810996 · Abbott Laboratories
KNT · Tubes, Gastrointestinal (and Accessories) · 15d
Cleared Mar 20, 1981
ALTERNATE STERILIZ. FOR CELLULOSE ACET
K810315 · Cordis Corp.
FKQ · System, Dialysate Delivery, Central Multiple Patient · 43d
Cleared Feb 19, 1981
CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY
K802894 · Cordis Corp.
FJI · Dialyzer, Capillary, Hollow Fiber · 94d
Cleared Feb 13, 1981
CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY
K802893 · Cordis Corp.
FJI · Dialyzer, Capillary, Hollow Fiber · 88d
Cleared Jan 29, 1981
INPERSOL CAPD BAG PORT CLAMP
K803300 · Abbott Laboratories
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 30d
Cleared Jan 15, 1981
CORDIS HAKIM ASCITES VALVE SYSTEM
K803258 · Cordis Corp.
KPM · Shunt, Peritoneal · 23d
Cleared Jan 07, 1981
C-PAK MODEL 12 ARTIFICIAL KIDNEY
K802613 · Cordis Corp.
FJI · Dialyzer, Capillary, Hollow Fiber · 78d
Cleared Dec 22, 1980
ADHESIVE PERISTOMAL COVERING W/WO CONN.
K803082 · Johnson & Johnson Professionals, Inc.
EXB · Collector, Ostomy · 17d
Cleared Nov 12, 1980
CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON
K802677 · Johnson & Johnson Professionals, Inc.
EXB · Collector, Ostomy · 14d
Cleared Oct 31, 1980
BARD MALE EXTERNAL CATHETER
K802433 · C.R. Bard, Inc.
KNX · Collector, Urine, (and Accessories) For Indwelling Catheter · 25d
Cleared Oct 10, 1980
INPERSOL-CAPD ADMINISTRATION SET
K801881 · Abbott Laboratories
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 64d
Cleared Aug 13, 1980
BK-6010 CATHETER TUBE HOLDER
K801711 · Fred Sammons, Inc.
KNX · Collector, Urine, (and Accessories) For Indwelling Catheter · 20d
Cleared Aug 13, 1980
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K801731 · Cordis Corp.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 19d
Cleared Aug 12, 1980
INPERSOL CAPD ADMIN. SET & CATHETER ADAP
K800993 · Abbott Laboratories
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 109d
Cleared Jul 28, 1980
SUPER BANISH DEODORANT
K801471 · Howmedica Corp.
EXB · Collector, Ostomy · 34d
Cleared Jul 28, 1980
NASO-GARD NASOGASTRIC TUBE HOLDER
K801511 · Howmedica Corp.
KNT · Tubes, Gastrointestinal (and Accessories) · 27d
Cleared Jul 14, 1980
LOW-ACETATE HEMODIALYSIS BATH CONCENTR.
K800624 · Travenol Laboratories, S.A.
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 117d

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All categories 2373 FGE Stents, Drains And Dilators For The Biliary Ducts 155 KNT Tubes, Gastrointestinal (and Accessories) 110 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 74 FGB Ureteroscope And Accessories, Flexible/rigid 70 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 66 PKL Hemostatic Metal Clip For The Gi Tract 49 FED Endoscopic Access Overtube, Gastroenterology-urology 48 ODC Endoscope Channel Accessory 47 FAD Stent, Ureteral 45 FAJ Cystoscope And Accessories, Flexible/rigid 44 OCX Endoscopic Irrigation/suction System 44 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 KNW Instrument, Biopsy 39 FDS Gastroscope And Accessories, Flexible/rigid 39