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
8431 Gastroenterology & Urology devices
Cleared
Oct 15, 2001
TORAYSULFONE DIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
426d
Cleared
Oct 15, 2001
CHIBA NEEDLE
FCG
Biopsy Needle
82d
Cleared
Oct 12, 2001
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
ESW
Prosthesis, Esophageal
45d
Cleared
Oct 11, 2001
BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
185d
Cleared
Oct 10, 2001
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
191d
Cleared
Oct 05, 2001
THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER
MNW
Analyzer, Body Composition
210d
Cleared
Oct 05, 2001
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Oct 04, 2001
DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
KPM
Shunt, Peritoneal
79d
Cleared
Oct 04, 2001
URETEX SUP PUBOURETHRAL SLING
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
30d
Cleared
Oct 03, 2001
MEDCOMP EXCELL SPLIT TIP CATHETER
MSD
Catheter, Hemodialysis, Implanted
244d
Cleared
Oct 03, 2001
MODIFICATION TO VAXCEL DIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
29d
Cleared
Oct 03, 2001
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
MSD
Catheter, Hemodialysis, Implanted
667d
Cleared
Sep 28, 2001
AQUA WATER TREATMENT FOR HEMODIALYSIS
FIP
Subsystem, Water Purification
212d
Cleared
Sep 27, 2001
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
FID
Tubing, Dialysate
202d
Cleared
Sep 27, 2001
VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
NLU
Forceps, Biopsy, Electric, Reprocessed
111d
Cleared
Sep 25, 2001
XBO1-824-18/19/20 BIOPSY FORCEPS
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
85d
Cleared
Sep 21, 2001
LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT
KNT
Tubes, Gastrointestinal (and Accessories)
142d
Cleared
Sep 21, 2001
LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET
KNT
Tubes, Gastrointestinal (and Accessories)
142d
Cleared
Sep 21, 2001
LH 500 ENTERAL FEEDING GRAVITY BAG SET
KNT
Tubes, Gastrointestinal (and Accessories)
142d
Cleared
Sep 19, 2001
LOWSLEY SUPRAPUBIC TRACTOR
KOB
Catheter, Suprapubic (and Accessories)
70d
Cleared
Sep 17, 2001
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
FFK
Lithotriptor, Electro-hydraulic
90d
Cleared
Sep 12, 2001
ANCHOR GUIDE LESION LOCALIZATION DEVICE
KNW
Instrument, Biopsy
76d
Cleared
Sep 11, 2001
CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
FFK
Lithotriptor, Electro-hydraulic
90d
Cleared
Sep 10, 2001
AQUANET, MODEL EC 2000
KPL
Colonic Irrigation System
614d
Cleared
Sep 07, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FGE
Stents, Drains And Dilators For The Biliary Ducts
88d
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