21 C.F.R. § 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
Title 21 - Food and Drugs
(a) Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart E—Neurological Surgical Devices
§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
