21 CFR § 882.4310 Neurological Devices

§ 882.4310 Powered simple 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. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

(b) Classification. Class II (performance standards).

← § 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.§ 882.4325 Cranial drill handpiece (brace). →