GEI

Electrosurgical, Cutting & Coagulation & Accessories

Product code

GEI

Device name

Electrosurgical, Cutting & Coagulation & Accessories

Device class

Class 2

21 CFR

21 CFR 878.4400

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

174

Summaries archived here

158 (direct download)

510(k) clearances (all years, FDA)

2314 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (174)

Last three years. Most recent: 2026-08-27.

158 summaries are archived here for direct download.