FTMClass II

Mesh, Surgical

21 CFR 878.3300 / General, Plastic Surgery

FTM is the FDA product code for Mesh, Surgical, a class II device type, regulated under 21 CFR 878.3300. As of 2026-09-10, FDA records hold 164 510(k) clearances under this code, the most recent dated 2026-08-12, and 76 recalls.

Classification record

Product code: FTM
Device name: Mesh, Surgical
Regulation: 21 CFR 878.3300
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: 164
Ingested recalls: 76

Clearances, product code FTM

By decision year

164 clearances under product code FTM with a decision year between 1982 and 2026, 2006 the highest year at 13.

Show the numbers

510(k) clearances under FDA product code FTM by decision year
Year	Clearances
1982	1
1983	5
1984	1
1985	3
1989	1
1990	1
1992	2
1993	1
1994	1
1996	3
1997	2
1998	3
1999	1
2000	3
2001	2
2002	7
2003	4
2004	12
2005	6
2006	13
2007	9
2008	9
2009	7
2010	2
2011	6
2012	4
2013	4
2014	8
2015	4
2016	7
2017	9
2018	2
2019	6
2020	4
2021	4
2023	2
2024	3
2025	1
2026	1

Applicants with the most clearances

Product code FTM

Applicants holding the most 510(k) clearances under product code FTM
Applicant	Clearances
Cook Biotech, Inc.	14
Bio-Vascular, Inc.	7
Integra LifeSciences Braintree Inc.	7
Cook Biotech Incorporated	6
DSM Biomedical, Inc.	6
LifeCell Corp	6
Organogenesis, Inc.	6
S. Jackson, Inc.	6
Boston Scientific Corporation	5
Xylos Corporation	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 70 companies shown, in name order