GEIClass II

Electrosurgical, Cutting & Coagulation & Accessories

21 CFR 878.4400 / General, Plastic Surgery

GEI is the FDA product code for Electrosurgical, Cutting & Coagulation & Accessories, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)". As of 2026-09-10, FDA records hold 2,314 510(k) clearances under this code, the most recent dated 2026-08-27, and 644 recalls.

Classification record

Product code: GEI
Device name: Electrosurgical, Cutting & Coagulation & Accessories
FDA definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Regulation: 21 CFR 878.4400
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: 2,319
Ingested recalls: 644

Clearances, product code GEI

By decision year

2,319 clearances under product code GEI with a decision year between 1976 and 2026, 1994 the highest year at 105.

Show the numbers

510(k) clearances under FDA product code GEI by decision year
Year	Clearances
1976	4
1977	18
1978	13
1979	22
1980	13
1981	17
1982	23
1983	23
1984	22
1985	25
1986	26
1987	13
1988	27
1989	12
1990	32
1991	49
1992	36
1993	48
1994	105
1995	87
1996	67
1997	76
1998	72
1999	62
2000	72
2001	51
2002	69
2003	72
2004	53
2005	51
2006	53
2007	50
2008	61
2009	42
2010	46
2011	35
2012	39
2013	48
2014	49
2015	47
2016	64
2017	52
2018	47
2019	48
2020	59
2021	46
2022	55
2023	65
2024	59
2025	52
2026	42

Applicants with the most clearances

Product code GEI

Applicants holding the most 510(k) clearances under product code GEI
Applicant	Clearances
Medtronic, Inc.	124
ArthroCare Corporation	86
Apyx Medical Corporation	52
Conmedcorp	43
Boston Scientific Corporation	38
Gyrus ACMI, Inc.	37
Megadyne Medical Products, Inc	32
ConMed Corporation	26
Erbe USA Inc	25
Ethicon Endo-Surgery Inc	25

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 735 companies shown, in name order