21 C.F.R. § 882.4305
Powered compound cranial drills, burrs, trephines, and their accessories.
Cite as 21 C.F.R. § 882.4305 (2026)
(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).