StacksVerified U.S. regulatory reference

21 CFR §878.4400

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II.