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
8429 Gastroenterology & Urology devices
Cleared
Mar 21, 2002
SAFYRE SLING SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
78d
Cleared
Mar 20, 2002
PELVICFLEXER EXERCISE DEVICE
HIR
Perineometer
293d
Cleared
Mar 19, 2002
INCARE PELVIC FLOOR THERAPY SYSTEM
HIR
Perineometer
134d
Cleared
Mar 19, 2002
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
FHN
Ligator, Hemorrhoidal
28d
Cleared
Mar 15, 2002
MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)
MUK
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
59d
Cleared
Mar 12, 2002
SONOPSY
FCG
Biopsy Needle
176d
Cleared
Mar 08, 2002
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
FIP
Subsystem, Water Purification
121d
Cleared
Mar 05, 2002
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
HIR
Perineometer
119d
Cleared
Mar 04, 2002
LIFEMATE MLA MULTI-LINE ADAPTOR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
312d
Cleared
Mar 04, 2002
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
KOB
Catheter, Suprapubic (and Accessories)
90d
Cleared
Mar 01, 2002
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
FGE
Stents, Drains And Dilators For The Biliary Ducts
108d
Cleared
Feb 28, 2002
SANDHILL SCIENTIFIC PEDIATEC PH PROBE
FFT
Electrode, Ph, Stomach
90d
Cleared
Feb 26, 2002
RUSCH MILLER-ABBOTT TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
347d
Cleared
Feb 26, 2002
RUSCH CANTOR TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
347d
Cleared
Feb 20, 2002
DFINER UROLOGICAL CATHETER
FGI
Catheter, Urethrographic, Male
133d
Cleared
Feb 19, 2002
PROTOCO2L INSUFFLATOR MODEL 6400
FCX
Insufflator, Automatic Carbon-dioxide For Endoscope
146d
Cleared
Feb 15, 2002
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY
EZL
Catheter, Retention Type, Balloon
137d
Cleared
Feb 14, 2002
REPROCESSED STONE RETRIEVAL BASKETS
FFL
Dislodger, Stone, Basket, Ureteral, Metal
189d
Cleared
Feb 14, 2002
REPROCESSED ENDOSCOPIC ELECTRODES
NLW
Electrode, Electrosurgical, Active, Urological, Reprocessed
184d
Cleared
Feb 12, 2002
MODIFICATION TO VISTA STEREOSCOPE SYSTEM
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
14d
Cleared
Feb 11, 2002
STONELITH, MODEL V5
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
306d
Cleared
Feb 11, 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
34d
Cleared
Feb 08, 2002
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
184d
Cleared
Feb 07, 2002
ENDOSCOPIC MULTI-FIRE CLIP APPLIER
PKL
Hemostatic Metal Clip For The Gi Tract
76d
Cleared
Feb 06, 2002
GENTLE COLONICS IRRIGATION SYSTEM
KPL
Colonic Irrigation System
574d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices