KNAClass II

Instrument, Manual, Specialized Obstetric-Gynecologic

21 CFR 884.4530 / Obstetrics/Gynecology

KNA is the FDA product code for Instrument, Manual, Specialized Obstetric-Gynecologic, a class II device type, regulated under 21 CFR 884.4530. As of 2026-09-10, FDA records hold 58 510(k) clearances under this code, the most recent dated 2014-01-10, and no recalls.

Classification record

Product code: KNA
Device name: Instrument, Manual, Specialized Obstetric-Gynecologic
Regulation: 21 CFR 884.4530
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 58
Ingested recalls: 0

Clearances, product code KNA

By decision year

58 clearances under product code KNA with a decision year between 1977 and 2014, 1994 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code KNA by decision year
Year	Clearances
1977	2
1978	1
1979	3
1980	1
1981	2
1984	1
1985	3
1986	1
1987	3
1988	2
1989	9
1992	1
1994	10
1995	2
1996	1
1997	2
1998	3
1999	2
2000	1
2002	2
2006	2
2009	1
2010	1
2011	1
2014	1

Applicants with the most clearances

Product code KNA

Applicants holding the most 510(k) clearances under product code KNA
Applicant	Clearances
Zinnanti Surgical Instruments, Inc.	9
Thomasville Medical Assoc.	8
Cook Incorporated	3
Precision Surgical Instrument, Inc.	3
Ackrad Laboratories	2
American V. Mueller	2
C. Intl.	2
Cook Ob/Gyn	2
Urogyn, Ltd.	2
Cook Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order