LYUClass I

Accessory, Surgical Apparel

21 CFR 878.4040 / General, Plastic Surgery

LYU is the FDA product code for Accessory, Surgical Apparel, a class I device type, regulated under 21 CFR 878.4040. As of 2026-09-10, FDA records hold 56 510(k) clearances under this code, the most recent dated 2001-06-22, and 9 recalls.

Classification record

Product code: LYU
Device name: Accessory, Surgical Apparel
Regulation: 21 CFR 878.4040
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: 56
Ingested recalls: 9

Clearances, product code LYU

By decision year

56 clearances under product code LYU with a decision year between 1988 and 2001, 1994 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code LYU by decision year
Year	Clearances
1988	2
1989	3
1990	5
1991	6
1992	2
1993	5
1994	15
1995	11
1996	3
1997	3
2001	1

Applicants with the most clearances

Product code LYU

Applicants holding the most 510(k) clearances under product code LYU
Applicant	Clearances
Medical Armor Corp.	5
Sloan Corp.	3
Wells Lamont Corp.	3
Aor-Sullivan	2
Depuy-Raynham	2
Derekduck Industries Corp.	2
Instrument Makar, Inc.	2
Lovell-Schenck, Inc.	2
Action Eyewear Corp.	1
Allied Signal, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 778 companies shown, in name order