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
169–192 of 476
Cleared Oct 24, 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
K012822
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 05, 2001
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K012993
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Sep 07, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
K012590
Cordis Corp.
Gastroenterology & Urology · 28d
Cleared Aug 27, 2001
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
K010411
Cordis Corp.
Gastroenterology & Urology · 196d
Cleared Aug 17, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K012216
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 32d
Cleared Aug 13, 2001
COOK ZILVER BILIARY STENT
K010242
Cook, Inc.
Gastroenterology & Urology · 200d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 18, 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K011881
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Jun 15, 2001
OMNILINK .035 BILIARY STENT SYSTEM
K011506
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared May 08, 2001
OMNILINK .018 BILIARY STENT SYSTEM
K011039
Guidant Corp.
Gastroenterology & Urology · 33d
Cleared Apr 12, 2001
RX HERCULINK PLUS BILIARY STENT SYSTEM
K010684
Guidant Corp.
Gastroenterology & Urology · 35d
Cleared Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K003929
Boston Scientific Corp
Gastroenterology & Urology · 92d
Cleared Mar 16, 2001
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
K010445
Cordis Corp.
Gastroenterology & Urology · 30d
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