FSYClass II

Light, Surgical, Ceiling Mounted

21 CFR 878.4580 / General, Plastic Surgery

FSY is the FDA product code for Light, Surgical, Ceiling Mounted, a class II device type, regulated under 21 CFR 878.4580. As of 2026-09-10, FDA records hold 74 510(k) clearances under this code, the most recent dated 2014-10-29, and 453 recalls.

Classification record

Product code: FSY
Device name: Light, Surgical, Ceiling Mounted
Regulation: 21 CFR 878.4580
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 74
Ingested recalls: 454

Clearances, product code FSY

By decision year

74 clearances under product code FSY with a decision year between 1977 and 2014, 2014 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code FSY by decision year
Year	Clearances
1977	1
1978	2
1982	1
1986	2
1987	1
1989	3
1990	4
1991	2
1992	2
1994	2
1996	3
1997	2
1998	4
1999	5
2000	2
2001	2
2002	1
2003	4
2004	4
2006	3
2007	3
2008	2
2009	2
2010	5
2012	2
2013	3
2014	7

Applicants with the most clearances

Product code FSY

Applicants holding the most 510(k) clearances under product code FSY
Applicant	Clearances
Berchtold Holding GmbH	9
Skytron, LLC	6
Burton Medical Products Corp.	5
Dr. Mach GmbH & Co. KG	4
Alm S.A.	3
Castle Co.	3
Kinetic Biomedical Services, Inc.	3
American Sterilizer Co.	2
Berchtold GmbH & Co. KG	2
Convida Healthcare & Systems Corporation	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 65 companies shown, in name order