GEHClass II

Unit, Cryosurgical, Accessories

21 CFR 878.4350 / General, Plastic Surgery

GEH is the FDA product code for Unit, Cryosurgical, Accessories, a class II device type, regulated under 21 CFR 878.4350. As of 2026-09-10, FDA records hold 263 510(k) clearances under this code, the most recent dated 2026-06-30, and 106 recalls.

Classification record

Product code: GEH
Device name: Unit, Cryosurgical, Accessories
Regulation: 21 CFR 878.4350
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 264
Ingested recalls: 106

Clearances, product code GEH

By decision year

264 clearances under product code GEH with a decision year between 1976 and 2026, 2016 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code GEH by decision year
Year	Clearances
1976	4
1977	3
1979	1
1980	2
1981	4
1983	3
1984	3
1985	1
1986	1
1987	2
1988	5
1989	2
1990	1
1991	3
1992	2
1993	4
1994	5
1995	4
1996	7
1997	10
1998	7
1999	6
2000	4
2001	4
2002	10
2003	8
2004	3
2005	6
2006	8
2007	6
2008	1
2009	4
2010	4
2011	7
2012	4
2013	4
2014	6
2015	11
2016	15
2017	12
2018	6
2019	6
2020	8
2021	6
2022	6
2023	8
2024	9
2025	10
2026	8

Applicants with the most clearances

Product code GEH

Applicants holding the most 510(k) clearances under product code GEH
Applicant	Clearances
Galil Medical Ltd.	29
Varian Medical Systems, Inc.	19
CSA Medical	14
PENTAX of America, Inc.	11
Cryomedical Sciences, Inc.	9
AtriCure, Inc.	8
Cryoconcepts LP	8
Cryosurgery, Inc.	8
Spembly Medical, Ltd.	8
Sanarus Medical, Inc.	7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 91 companies shown, in name order