Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 882  /  Sec. 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.

(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).