21 C.F.R. § 882.4300

Manual cranial drills, burrs, trephines, and their accessories

Last amended: 2016Year: 2026Length: 33 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 882.4300 (2026)

(a) Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull. (b) Classification. Class II (performance standards).
21 C.F.R. § 882.4300: Manual cranial drills, burrs, trephines, and their accessories | Justis AI