FYAClass II

Gown, Surgical

21 CFR 878.4040 / General, Plastic Surgery

FYA is the FDA product code for Gown, Surgical, a class II device type, regulated under 21 CFR 878.4040. As of 2026-09-10, FDA records hold 298 510(k) clearances under this code, the most recent dated 2026-08-26, and 129 recalls.

Classification record

Product code: FYA
Device name: Gown, Surgical
Regulation: 21 CFR 878.4040
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 298
Ingested recalls: 129

Clearances, product code FYA

By decision year

298 clearances under product code FYA with a decision year between 1976 and 2026, 2022 the highest year at 24.

Show the numbers

510(k) clearances under FDA product code FYA by decision year
Year	Clearances
1976	4
1977	1
1978	2
1979	1
1980	5
1981	3
1982	4
1983	1
1984	2
1985	5
1986	2
1987	2
1988	5
1989	6
1990	3
1991	3
1992	9
1993	16
1994	12
1995	8
1996	6
1997	5
1998	5
1999	8
2000	9
2001	6
2002	6
2003	6
2004	4
2005	10
2006	5
2007	6
2008	4
2009	6
2010	4
2011	8
2012	4
2013	2
2014	5
2015	3
2016	3
2017	4
2018	2
2019	5
2020	7
2021	17
2022	24
2023	12
2024	5
2025	4
2026	9

Applicants with the most clearances

Product code FYA

Applicants holding the most 510(k) clearances under product code FYA
Applicant	Clearances
MEDLINE INDUSTRIES, LP - Northfield	16
Standard Textile Co., Inc.	14
Medtronic, Inc.	12
Kimberly-Clark Corporation	12
Stryker Corp.	11
The Sewing Source, Inc.	8
The Buckeye Cellulose Corp.	7
Baxter Healthcare Corporation	6
Foshan Nanhai Plus Medical Co Ltd	5
Procter & Gamble Mfg. Co.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 200 companies shown, in name order