GAMClass II

Suture, Absorbable, Synthetic, Polyglycolic Acid

21 CFR 878.4493 / General, Plastic Surgery

GAM is the FDA product code for Suture, Absorbable, Synthetic, Polyglycolic Acid, a class II device type, regulated under 21 CFR 878.4493. As of 2026-09-10, FDA records hold 149 510(k) clearances under this code, the most recent dated 2026-06-25, and 130 recalls.

Classification record

Product code: GAM
Device name: Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation: 21 CFR 878.4493
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 149
Ingested recalls: 130

Clearances, product code GAM

By decision year

149 clearances under product code GAM with a decision year between 1991 and 2026, 2014 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code GAM by decision year
Year	Clearances
1991	1
1992	1
1993	2
1994	2
1995	7
1996	4
1997	5
1998	4
1999	5
2000	3
2001	6
2002	6
2003	7
2004	7
2005	8
2006	5
2007	7
2008	6
2009	3
2010	1
2011	2
2012	5
2013	1
2014	10
2015	5
2016	3
2017	8
2018	5
2019	4
2020	3
2021	2
2022	2
2023	1
2024	2
2025	3
2026	3

Applicants with the most clearances

Product code GAM

Applicants holding the most 510(k) clearances under product code GAM
Applicant	Clearances
Ethicon, Inc	27
United States Surgical, A Division of Tyco Healthc	12
Surgical Specialties Corp	8
Aesculap Inc	7
Foosin Medical Supplies Inc., Ltd.	5
Coapt Systems, Inc.	4
Davis & Geck, Inc.	4
Internacional Farmaceutica, S.A. de C.V.	4
ORIGAMI SURGICAL Inc.	4
United Medical Industries Co. Ltd.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 118 companies shown, in name order