21 C.F.R. § 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart E—Neurological Surgical Devices
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
