21 CFR § 882.4300 Neurological Devices

§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories

Current through Sep 8, 2026 · Read all of Part 882

⚠ 2 pending changes to Part 882

(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).

← § 882.4275 Dowel cutting instrument.§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories. →