CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 882—NEUROLOGICAL DEVICES > SUBPART E—Neurological Surgical Devices (§882.4030 to §882.4900) > 882.4310—Powered simple cranial drills, burrs, trephines, and their accessories.

882.4310—Powered simple cranial drills, burrs, trephines, and their accessories.

(a) Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.
(b) Classification. Class II (performance standards).