21 CFR 888.4580
§ 888.4580 Sonic surgical instrument and accessories/attachments.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 888.4580, § 888.4580 Sonic surgical instrument and accessories/attachments, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91145
- Permanent ID
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Full text
(a) Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.