21 CFR § 882.4305
Powered compound cranial drills, burrs, trephines, and their accessories
June 25, 2020
(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).