GADClass I

Retractor

21 CFR 878.4800 / General, Plastic Surgery

GAD is the FDA product code for Retractor, a class I device type, regulated under 21 CFR 878.4800. As of 2026-09-10, FDA records hold 100 510(k) clearances under this code, the most recent dated 2016-04-13, and 44 recalls.

Classification record

Product code: GAD
Device name: Retractor
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: 100
Ingested recalls: 44

Clearances, product code GAD

By decision year

100 clearances under product code GAD with a decision year between 1976 and 2016, 1988 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code GAD by decision year
Year	Clearances
1976	2
1977	4
1978	4
1979	5
1980	4
1981	3
1982	2
1983	3
1984	11
1985	10
1986	3
1987	3
1988	12
1989	9
1990	1
1991	1
1992	6
1993	4
1994	4
1996	1
1998	1
2000	1
2005	2
2007	1
2013	1
2016	2

Applicants with the most clearances

Product code GAD

Applicants holding the most 510(k) clearances under product code GAD
Applicant	Clearances
T. Korossurgical Instruments Corp.	8
Edward Weck, Inc.	4
Karlin Technology, Inc.	3
Kinetic Medical Products	3
Medin Corp.	3
Minnesota Scientific, Inc.	3
The Huxley Instrument Corp.	3
3M Company	2
Acme United Corp.	2
Adept-Med Intl., Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 615 companies shown, in name order