Product code GEI

Device name

Electrosurgical, Cutting & Coagulation & Accessories

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4400

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

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).

Source

FDA openFDA device classification dataset