KOAClass I

Surgical Instruments, G-U, Manual (And Accessories)

21 CFR 876.4730 / Gastroenterology, Urology

KOA is the FDA product code for Surgical Instruments, G-U, Manual (And Accessories), a class I device type, regulated under 21 CFR 876.4730. As of 2026-09-10, FDA records hold 44 510(k) clearances under this code, the most recent dated 2018-12-07, and 6 recalls.

Classification record

Product code: KOA
Device name: Surgical Instruments, G-U, Manual (And Accessories)
Regulation: 21 CFR 876.4730
Device class: Class I
Review panel: Gastroenterology, Urology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 44
Ingested recalls: 6

Clearances, product code KOA

By decision year

44 clearances under product code KOA with a decision year between 1976 and 2018, 1985 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code KOA by decision year
Year	Clearances
1976	3
1977	2
1980	3
1981	5
1982	3
1983	2
1984	5
1985	7
1986	1
1987	1
1989	3
1992	4
1993	2
1994	1
1995	1
2018	1

Applicants with the most clearances

Product code KOA

Applicants holding the most 510(k) clearances under product code KOA
Applicant	Clearances
The Huxley Instrument Corp.	5
Imm Enterprises, Ltd.	4
Lone Star Medical Products	3
V. Mueller O.V. Baxter Healthcare Corp.	3
Cook Incorporated	2
J. Sklar Mfg. Co., Inc.	2
Ace Orthopedic Manufacturing Co.	1
Agency for Medical Innovations Inc.	1
American Convertors Div., American Pharmaseal	1
American V. Mueller	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 97 companies shown, in name order