GBMClass II

Catheter, Urethral

21 CFR 876.5130 / Gastroenterology, Urology

GBM is the FDA product code for Catheter, Urethral, a class II device type, regulated under 21 CFR 876.5130. As of 2026-09-10, FDA records hold 71 510(k) clearances under this code, the most recent dated 2025-03-05, and 18 recalls.

Classification record

Product code: GBM
Device name: Catheter, Urethral
Regulation: 21 CFR 876.5130
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 71
Ingested recalls: 18

Clearances, product code GBM

By decision year

71 clearances under product code GBM with a decision year between 1976 and 2025, 2019 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code GBM by decision year
Year	Clearances
1976	3
1983	1
1987	1
1988	1
1989	1
1990	2
1991	1
1992	1
1993	1
1994	1
1995	2
1996	1
1997	2
1998	1
1999	2
2001	2
2002	1
2003	3
2004	1
2005	1
2006	1
2007	2
2009	1
2011	2
2012	3
2014	1
2015	5
2016	3
2017	2
2018	6
2019	7
2020	6
2022	2
2025	1

Applicants with the most clearances

Product code GBM

Applicants holding the most 510(k) clearances under product code GBM
Applicant	Clearances
MEDLINE INDUSTRIES, LP - Northfield	14
Hollister Incorporated	10
Astra Tech, Inc.	3
B.Braun Medical, Inc.	3
C.R. Bard Inc	3
Robling Medical, LLC	2
ConvaTec Limited	2
Cook Incorporated	2
Hakki Medical Technologies, Inc.	2
Hangzhou Bever Medical Devices Co., Ltd.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 64 companies shown, in name order