21 CFR § 882.4305 Neurological Devices

§ 882.4305 Powered compound 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 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).

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