21 CFR § 878.4400 General and Plastic Surgery Devices

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

Current through Sep 8, 2026 · Read all of Part 878

⚠ 2 pending changes to Part 878

(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.

← § 878.4380 Drape adhesive.§ 878.4405 Focused ultrasound system for non-thermal, mechanical tissue ablation. →