FGE · Class II · 21 CFR 876.5010

FDA Product Code FGE: Stents, Drains And Dilators For The Biliary Ducts

FDA product code FGE covers stents, drains, and dilators for the biliary ducts.

These devices are used endoscopically or percutaneously to restore and maintain patency of the bile duct when obstructed by stones, strictures, or malignancy. Biliary stents are the mainstay of palliative treatment for malignant biliary obstruction and are also used in benign strictures following liver transplant or injury.

FGE devices are Class II medical devices, regulated under 21 CFR 876.5010 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Cordis Corp., Boston Scientific Corp and Cook, Inc..

476
Total
476
Cleared
127d
Avg days
1982
Since
476 devices
217–240 of 476
Cleared Jan 09, 2001
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
K003186
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 05, 2001
BARD LUMINEXX BILIARY STENT
K003793
C.R. Bard, Inc.
Gastroenterology & Urology · 28d
Cleared Jan 04, 2001
GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
K003753
Uresil Corp.
Gastroenterology & Urology · 30d
Cleared Nov 22, 2000
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K003336
Cordis Corp.
Gastroenterology & Urology · 28d
Cleared Nov 22, 2000
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
K003365
Cordis Corp.
Gastroenterology & Urology · 26d
Cleared Oct 12, 2000
NIR BILLIARY STENT SYSTEM
K002133
Boston Scientific Corp
Gastroenterology & Urology · 90d
Cleared Oct 12, 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
K002143
Guidant Corp.
Gastroenterology & Urology · 87d
Cleared Aug 30, 2000
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
K001338
Boston Scientific Corp
Gastroenterology & Urology · 125d
Cleared Jul 31, 2000
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
K002101
AngioDynamics, Inc.
Gastroenterology & Urology · 49d
Cleared Jul 18, 2000
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K001843
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jun 27, 2000
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
K001258
Cordis Corp.
Gastroenterology & Urology · 70d
Cleared May 19, 2000
WALLSTENT BILIARY ENDOPROSTHESIS
K000308
Boston Scientific Corp
Gastroenterology & Urology · 108d
Cleared May 17, 2000
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1
K001222
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared May 17, 2000
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
K001224
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Apr 12, 2000
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
K000793
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Mar 23, 2000
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
K000564
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Mar 23, 2000
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
K993303
Boston Scientific Corp
Gastroenterology & Urology · 171d
Cleared Mar 17, 2000
OTW MEGALINK SDS BILIARY STENT SYSTEM
K000550
Advanced Cardiovascular Systems, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 01, 2000
INTRASTENT DOUBLESTRUT LD
K993904
Intratherapeutics, Inc.
Gastroenterology & Urology · 76d
Cleared Jan 07, 2000
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
K994156
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jan 06, 2000
BARD MEMOTHERM FLEXX BILIARY STENT
K993392
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 06, 2000
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
K993892
C.R. Bard, Inc.
Gastroenterology & Urology · 51d
Cleared Dec 30, 1999
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K993232
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 94d
Cleared Dec 23, 1999
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K994068
Cordis Corp.
Gastroenterology & Urology · 21d