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 C.R. Bard, Inc..

474
Total
474
Cleared
127d
Avg days
1982
Since
474 devices
121–144 of 474
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 23, 1999
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K994068
Cordis Corp.
Gastroenterology & Urology · 21d
Cleared Nov 28, 1999
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K993646
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Oct 29, 1999
PALMAZ XL TANSHEPATIC BILIARY STENTS
K993091
Cordis Corp.
Gastroenterology & Urology · 43d
Cleared Aug 12, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
K991674
Cordis Corp.
Gastroenterology & Urology · 87d
Cleared Aug 04, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
K991028
Cordis Corp.
Gastroenterology & Urology · 128d
Cleared Apr 30, 1999
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
K990631
Cordis Corp.
Gastroenterology & Urology · 63d
Cleared Dec 18, 1998
CORDIS NITINOL STENT AND DELIVERY SYSTEM
K980823
Cordis Corp.
Gastroenterology & Urology · 290d
Cleared Oct 16, 1998
FLEXIMA
K982508
Boston Scientific Corp
Gastroenterology & Urology · 88d
Cleared Jun 09, 1998
PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
K980653
Cordis Corp.
Gastroenterology & Urology · 118d
Cleared Dec 15, 1997
COURIER ST BALLOON DILATATION CATHETER
K973008
Boston Scientific Corp
Gastroenterology & Urology · 124d
Cleared Nov 10, 1997
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM
K973113
Boston Scientific Corp
Gastroenterology & Urology · 82d
Cleared Oct 07, 1997
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
K972825
Cordis Corp.
Gastroenterology & Urology · 90d
Cleared Jun 30, 1997
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
K965147
Boston Scientific Corp
Gastroenterology & Urology · 189d
Cleared Jun 20, 1997
LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
K964688
Cordis Corp.
Gastroenterology & Urology · 210d
Cleared May 21, 1997
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K963254
Boston Scientific Corp
Gastroenterology & Urology · 275d
Cleared May 20, 1997
ULTRAFLEX DIAMOND
K962899
Boston Scientific Corp
Gastroenterology & Urology · 299d
Cleared May 02, 1997
BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
K963782
C.R. Bard, Inc.
Gastroenterology & Urology · 224d
Cleared Mar 25, 1997
EXTRACTORRX
K970052
Boston Scientific Corp
Gastroenterology & Urology · 77d
Cleared Dec 12, 1996
COURIER BALLOON DILATATION CATHETER
K963691
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Nov 25, 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K963397
Boston Scientific Corp
Gastroenterology & Urology · 88d
Cleared May 08, 1996
CORDIS BILIARY STENT
K955728
Cordis Corp.
Gastroenterology & Urology · 142d
Cleared Sep 28, 1994
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
K930623
Boston Scientific Corp
Gastroenterology & Urology · 597d
Cleared May 20, 1994
ELIMINATOR BALLOON DILATOR
K940965
C.R. Bard, Inc.
Gastroenterology & Urology · 79d