GCYClass I

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

21 CFR 878.4680 / General, Plastic Surgery

GCY is the FDA product code for Apparatus, Suction, Single Patient Use, Portable, Nonpowered, a class I device type, regulated under 21 CFR 878.4680. As of 2026-09-10, FDA records hold 96 510(k) clearances under this code, the most recent dated 1997-10-01, and 107 recalls.

Classification record

Product code: GCY
Device name: Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Regulation: 21 CFR 878.4680
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: 96
Ingested recalls: 107

Clearances, product code GCY

By decision year

96 clearances under product code GCY with a decision year between 1976 and 1997, 1980 the highest year at 17.

Show the numbers

510(k) clearances under FDA product code GCY by decision year
Year	Clearances
1976	7
1977	1
1978	4
1979	3
1980	17
1981	5
1982	5
1983	4
1984	3
1985	7
1986	5
1987	2
1988	5
1989	2
1990	3
1991	2
1992	3
1993	11
1994	2
1995	1
1996	2
1997	2

Applicants with the most clearances

Product code GCY

Applicants holding the most 510(k) clearances under product code GCY
Applicant	Clearances
Snyder Laboratories, Inc.	5
Pudenz-Schulte Medical Research Corp.	4
Sherwood Medical Co.	4
Cerenovus, Inc.	3
Davol, Inc.	3
Inamed Development Co.	3
Inman Medical Corp.	3
American Heyer Schulte	2
BD Becton Dickinson Vacutainer Systems Preanalytic	2
Dow Corning Corp. Healthcare Industries Materials	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 193 companies shown, in name order