21 CFR 882.4305
§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.4305, § 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90689
- Permanent ID
ys:prov:90689@1- SHA-256
d2e58b578094ebdc21e7e61fbea136c656aab700721f50721c20d8baef2d50c5
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.