FRGClass II

Wrap, Sterilization

21 CFR 880.6850 / General Hospital

FRG is the FDA product code for Wrap, Sterilization, a class II device type, regulated under 21 CFR 880.6850. As of 2026-09-10, FDA records hold 323 510(k) clearances under this code, the most recent dated 2026-07-02, and 50 recalls.

Classification record

Product code: FRG
Device name: Wrap, Sterilization
Regulation: 21 CFR 880.6850
Device class: Class II
Review panel: General Hospital
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 323
Ingested recalls: 50

Clearances, product code FRG

By decision year

323 clearances under product code FRG with a decision year between 1976 and 2026, 1994 the highest year at 22.

Show the numbers

510(k) clearances under FDA product code FRG by decision year
Year	Clearances
1976	3
1977	7
1978	7
1979	2
1980	7
1981	11
1982	13
1983	8
1984	13
1985	7
1986	2
1987	5
1988	3
1989	2
1990	1
1991	1
1992	6
1993	4
1994	22
1995	6
1996	17
1997	6
1999	7
2000	3
2001	3
2002	3
2003	6
2004	4
2005	1
2006	5
2007	3
2008	2
2009	4
2010	4
2011	6
2012	10
2013	6
2014	8
2015	12
2016	9
2017	9
2018	5
2019	9
2020	5
2021	4
2022	9
2023	9
2024	11
2025	9
2026	4

Applicants with the most clearances

Product code FRG

Applicants holding the most 510(k) clearances under product code FRG
Applicant	Clearances
Cardinal Health200, LLC	11
Kimberly-Clark Corporation	11
MEDLINE INDUSTRIES, LP - Northfield	11
Case Medical, Inc.	9
Medtronic, Inc.	8
STERIS Corporation	8
Custom Pack Reliability	7
Wipak Oy	7
Aesculap Inc	6
Andersen Sterilizers, Inc.	6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 178 companies shown, in name order