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
8425 Gastroenterology & Urology devices
Cleared
Mar 17, 2003
BARD AQUAGUIDE URETERAL CONDUIT
FED
Endoscopic Access Overtube, Gastroenterology-urology
34d
Cleared
Mar 17, 2003
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
FAD
Stent, Ureteral
26d
Cleared
Mar 14, 2003
SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
88d
Cleared
Mar 11, 2003
VACUFLASH BIOPSY SYSTEM
KNW
Instrument, Biopsy
90d
Cleared
Mar 10, 2003
LIFESTENT BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
172d
Cleared
Mar 10, 2003
IRRIGATION SETS
LJH
System, Irrigation, Urological
116d
Cleared
Mar 10, 2003
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
31d
Cleared
Mar 10, 2003
AMERICAN CATHETER, MODEL W3
EZD
Catheter, Straight
18d
Cleared
Mar 07, 2003
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
PAG
Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
23d
Cleared
Mar 05, 2003
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
224d
Cleared
Mar 04, 2003
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
90d
Cleared
Feb 28, 2003
CATHETER CONNECTOR
KNY
Accessories, Catheter, G-u
119d
Cleared
Feb 28, 2003
ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
88d
Cleared
Feb 27, 2003
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
171d
Cleared
Feb 27, 2003
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
LJE
Catheter, Nephrostomy
80d
Cleared
Feb 27, 2003
MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
28d
Cleared
Feb 24, 2003
MEDCOMP SC4
MSD
Catheter, Hemodialysis, Implanted
196d
Cleared
Feb 24, 2003
CLOCKMINI, MODEL DF301
MNW
Analyzer, Body Composition
90d
Cleared
Feb 21, 2003
SYNTRA + DIALYZER, MODEL 200
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
113d
Cleared
Feb 20, 2003
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
PKL
Hemostatic Metal Clip For The Gi Tract
90d
Cleared
Feb 19, 2003
ENDO-GLIDE GUIDEWIRE
OCY
Endoscopic Guidewire, Gastroenterology-urology
114d
Cleared
Feb 19, 2003
PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
89d
Cleared
Feb 14, 2003
SMARTSTITCH M-CONNECTOR, MODEL OM-8005
OCW
Endoscopic Tissue Approximation Device
88d
Cleared
Feb 11, 2003
HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM
FIP
Subsystem, Water Purification
176d
Cleared
Feb 11, 2003
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
134d
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