Device type

Electrosurgical, Cutting & Coagulation & Accessories

Product code GEI · Class II · 21 CFR 878.4400 · General, Plastic Surgery

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).

FDA classification database