KNWClass II

Instrument, Biopsy

21 CFR 876.1075 / Gastroenterology, Urology

KNW is the FDA product code for Instrument, Biopsy, a class II device type, regulated under 21 CFR 876.1075. As of 2026-09-10, FDA records hold 365 510(k) clearances under this code, the most recent dated 2026-08-28, and 106 recalls.

Classification record

Product code: KNW
Device name: Instrument, Biopsy
Regulation: 21 CFR 876.1075
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 365
Ingested recalls: 107

Clearances, product code KNW

By decision year

365 clearances under product code KNW with a decision year between 1976 and 2026, 1998 the highest year at 34.

Show the numbers

510(k) clearances under FDA product code KNW by decision year
Year	Clearances
1976	1
1977	1
1978	1
1981	2
1982	2
1985	12
1986	4
1987	10
1988	6
1989	8
1990	7
1991	5
1992	6
1993	5
1994	12
1995	8
1996	10
1997	12
1998	34
1999	15
2000	7
2001	11
2002	12
2003	8
2004	11
2005	9
2006	4
2007	6
2008	4
2009	6
2010	3
2011	10
2012	7
2013	3
2014	8
2015	10
2016	9
2017	8
2018	7
2019	5
2020	8
2021	9
2022	8
2023	7
2024	5
2025	12
2026	7

Applicants with the most clearances

Product code KNW

Applicants holding the most 510(k) clearances under product code KNW
Applicant	Clearances
Medical Device Technologies, Inc.	15
Argon Medical Devices, Inc	12
C.R. Bard Inc	11
Gallini U.S., LLC	10
Ranfac Corp.	9
Senorx, Inc.	9
Bard Peripheral Vascular Inc	8
Daum Corp.	8
Devicor Medical Products Inc	7
Ethicon Endo-Surgery Inc	7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 164 companies shown, in name order