FSMClass I

Tray, Surgical, Instrument

21 CFR 878.4800 / General, Plastic Surgery

FSM is the FDA product code for Tray, Surgical, Instrument, a class I device type, regulated under 21 CFR 878.4800. As of 2026-09-10, FDA records hold 76 510(k) clearances under this code, the most recent dated 1997-05-06, and 36 recalls.

Classification record

Product code: FSM
Device name: Tray, Surgical, Instrument
Regulation: 21 CFR 878.4800
Device class: Class I
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: 76
Ingested recalls: 36

Clearances, product code FSM

By decision year

76 clearances under product code FSM with a decision year between 1976 and 1997, 1984 the highest year at 13.

Show the numbers

510(k) clearances under FDA product code FSM by decision year
Year	Clearances
1976	3
1977	1
1978	1
1979	4
1980	7
1981	5
1982	3
1983	8
1984	13
1985	2
1986	6
1987	5
1988	3
1989	1
1990	3
1991	8
1994	1
1996	1
1997	1

Applicants with the most clearances

Product code FSM

Applicants holding the most 510(k) clearances under product code FSM
Applicant	Clearances
Medcare Products	5
Ascep, Inc.	4
Medical Device Inspection Company	4
American Pharmaseal Div. Ahsc	3
Associated Medical Products Co.	3
E.M. Adams Co., Inc.	3
Edward Weck, Inc.	3
Medical Sterilization, Inc.	3
Terray Manufacturing, Inc.	2
A.D.T. Lab Industries	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 816 companies shown, in name order