21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories.

Regulations last checked for updates: Feb 13, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart E [§ 878.4010 - § 878.5050]

§ 878.4400 - Electrosurgical cutting and coagulation device and accessories.

(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 53 FR 23872, June 24, 1988, unless otherwise noted.

cite as: 21 CFR 878.4400