GDWClass II

Staple, Implantable

21 CFR 878.4750 / General, Plastic Surgery

GDW is the FDA product code for Staple, Implantable, a class II device type, regulated under 21 CFR 878.4750. As of 2026-09-10, FDA records hold 283 510(k) clearances under this code, the most recent dated 2026-05-11, and 225 recalls.

Classification record

Product code: GDW
Device name: Staple, Implantable
Regulation: 21 CFR 878.4750
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: 284
Ingested recalls: 225

Clearances, product code GDW

By decision year

284 clearances under product code GDW with a decision year between 1976 and 2026, 2014 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code GDW by decision year
Year	Clearances
1976	1
1977	1
1978	2
1980	1
1981	1
1982	2
1983	3
1984	4
1985	1
1986	2
1988	2
1989	5
1990	3
1991	10
1992	5
1993	2
1994	1
1995	2
1996	1
1997	1
1998	2
1999	3
2000	6
2001	5
2002	9
2003	11
2004	9
2005	6
2006	8
2007	8
2008	7
2009	13
2010	10
2011	11
2012	9
2013	13
2014	15
2015	8
2016	11
2017	13
2018	7
2019	12
2020	10
2021	9
2022	7
2023	4
2024	2
2025	3
2026	3

Applicants with the most clearances

Product code GDW

Applicants holding the most 510(k) clearances under product code GDW
Applicant	Clearances
Ethicon Endo-Surgery Inc	44
United States Surgical, A Division of Tyco Healthc	28
Medtronic, Inc.	27
Power Medical Interventions, Inc.	22
C.R. Bard Inc	10
Ethicon, Inc	10
Covidien, Formerly US Surgical A Divison of Tyco H	8
Cardica, Inc.	5
Ezisurg Medical Co., Ltd.	5
Incisive Surgical, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 119 companies shown, in name order