21 C.F.R. § 882.4305

Powered compound cranial drills, burrs, trephines, and their accessories.

Last amended: 2016Year: 2026Length: 54 wordsSubsections: 2Official source

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).
21 C.F.R. § 882.4305: Powered compound cranial drills, burrs, trephines, and their accessories. | Justis AI