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
8404 Gastroenterology & Urology devices
2726–2750 of 8404
Cleared Mar 22, 2010
SYSTEMS INTEGRATION MODEL: ENDOALPHA
K100345 · Olympus Medical Systems Corporation
ODA · Endoscopic Central Control Unit · 45d
Cleared Mar 19, 2010
REPROCESSED TROCARS, MODEL B5LT AND CB5LT
K100080 · Ascent Healthcare Solutions
NLM · Laparoscope, General & Plastic Surgery, Reprocessed · 66d
Cleared Mar 18, 2010
LED LIGHT SOURCE
K093792 · Sunoptic Technologies, LLC
FCW · Light Source, Fiberoptic, Routine · 98d
Cleared Mar 17, 2010
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
K100520 · Nipro Medical Corporation
FIE · Needle, Fistula · 22d
Cleared Mar 16, 2010
SCUBA BILIARY STENT SYSTEM
K092352 · Invatec S.P.A.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 224d
Cleared Mar 16, 2010
GYNECARE TVT EXACT CONTINENCE SYSTEM
K100485 · Ethicon, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 25d
Cleared Mar 11, 2010
SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
K091656 · Organ Recovery Systems, Inc.
KDL · Set, Perfusion, Kidney, Disposable · 275d
Cleared Mar 10, 2010
INBODY, MODELS: 270, R20, R20B
K092786 · Biospace Corporation Limited
MNW · Analyzer, Body Composition · 181d
Cleared Mar 10, 2010
OLYMPUS CHF TYPE Y0003
K093507 · Olympus Medical Systems Corporation
FBN · Choledochoscope And Accessories, Flexible/rigid · 117d
Cleared Mar 09, 2010
CLEARPATH UGI
K093779 · Easyglide , Ltd.
FDS · Gastroscope And Accessories, Flexible/rigid · 90d
Cleared Feb 26, 2010
ASEPT PERITONEAL DRAINAGE SYSTEM
K093796 · Pfm Medical, Inc.
PNG · Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling · 77d
Cleared Feb 24, 2010
GYRUS ACMI PK BUTTON ELECTRODE
K093181 · Gyrus Acmi, Inc.
FAS · Electrode, Electrosurgical, Active, Urological · 139d
Cleared Feb 23, 2010
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK
K093653 · Uresil, LLC
KNT · Tubes, Gastrointestinal (and Accessories) · 90d
Cleared Feb 22, 2010
BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
K092144 · Endochoice, Inc.
ESW · Prosthesis, Esophageal · 222d
Cleared Feb 22, 2010
ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
K093718 · Zutron Medical, LLC
FCY · Bulb, Inflation, For Endoscope · 82d
Cleared Feb 18, 2010
DIALOG WITH ADIMEA OPTION
K083460 · B. Braun Avitum AG
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 454d
Cleared Feb 18, 2010
DURASPAN HEMODIALYSIS LONG-TERM CATHETER
K100169 · R4 Vascular, Inc.
MSD · Catheter, Hemodialysis, Implanted · 29d
Cleared Feb 17, 2010
XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170
K093120 · Baxter Healthcare Corporation - Renal Division
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 138d
Cleared Feb 16, 2010
SCOPE INTRODUCER MODEL 7400
K093329 · N.M. Beale Co., Inc.
ODC · Endoscope Channel Accessory · 113d
Cleared Feb 09, 2010
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
K093379 · Bl Healthcare, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 103d
Cleared Feb 09, 2010
JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300
K093637 · Jms North America Corp.
FIE · Needle, Fistula · 77d
Cleared Jan 27, 2010
ALPHAXENON LIGHT 180 W AND 300 W
K093125 · Gimmi GmbH
GCT · Light Source, Endoscope, Xenon Arc · 117d
Cleared Jan 22, 2010
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
K093985 · Nipro Medical Corp.
FIE · Needle, Fistula · 29d
Cleared Jan 21, 2010
MEDLINE RED RUBBER URETHRAL CATHETER
K092250 · Medline Industries, Inc.
EYB · Catheter, Ureteral, Gastro-urology · 177d
Cleared Jan 21, 2010
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
K093195 · Cook Ireland, Ltd.
FCG · Biopsy Needle · 104d

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

Search all Gastroenterology & Urology 510(k) devices

Filter by Product Code

All categories 8404 KNT Tubes, Gastrointestinal (and Accessories) 524 FGE Stents, Drains And Dilators For The Biliary Ducts 460 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 331 KNW Instrument, Biopsy 279 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 168 KOD Catheter, Urological 164 KOC Accessories, Blood Circuit, Hemodialysis 145 MSD Catheter, Hemodialysis, Implanted 124 EZL Catheter, Retention Type, Balloon 119 FJI Dialyzer, Capillary, Hollow Fiber 119 FAD Stent, Ureteral 113 FGB Ureteroscope And Accessories, Flexible/rigid 112 FDF Colonoscope And Accessories, Flexible/rigid 111 FIP Subsystem, Water Purification 105 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 104