FGEClass II

Stents, Drains And Dilators For The Biliary Ducts

21 CFR 876.5010 / Gastroenterology, Urology

FGE is the FDA product code for Stents, Drains And Dilators For The Biliary Ducts, a class II device type, regulated under 21 CFR 876.5010. As of 2026-09-10, FDA records hold 476 510(k) clearances under this code, the most recent dated 2026-07-27, and 449 recalls.

Classification record

Product code: FGE
Device name: Stents, Drains And Dilators For The Biliary Ducts
Regulation: 21 CFR 876.5010
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 478
Ingested recalls: 450

Clearances, product code FGE

By decision year

478 clearances under product code FGE with a decision year between 1982 and 2026, 2003 the highest year at 40.

Show the numbers

510(k) clearances under FDA product code FGE by decision year
Year	Clearances
1982	2
1983	3
1984	6
1985	10
1986	7
1987	3
1988	2
1989	10
1990	19
1991	22
1992	12
1993	2
1994	6
1995	12
1996	11
1997	15
1998	10
1999	26
2000	25
2001	31
2002	21
2003	40
2004	25
2005	17
2006	12
2007	4
2008	11
2009	7
2010	9
2011	9
2012	8
2013	5
2014	8
2015	8
2016	4
2017	9
2018	7
2019	2
2020	4
2021	1
2022	6
2023	6
2024	6
2025	7
2026	8

Applicants with the most clearances

Product code FGE

Applicants holding the most 510(k) clearances under product code FGE
Applicant	Clearances
Boston Scientific Corporation	94
Cordis US Corp.	38
Medtronic, Inc.	24
Wilson-Cook Medical Inc.	20
Cook Inc.	19
C.R. Bard Inc	16
Cook Ireland Ltd.	11
Intratherapeutics, Inc.	11
Orbusneich Medical, Inc.	8
Edwards Lifesciences LLC	7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 113 companies shown, in name order