GroundRules
21 CFR 878.4400: Electrosurgical cutting and coagulation device and accessories.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 878—GENERAL AND PLASTIC SURGERY DEVICES
- Subpart E—Surgical Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON