21 C.F.R. § 888.4580 Sonic surgical instrument and accessories/attachments.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart E—Surgical Devices
§ 888.4580 Sonic surgical instrument and accessories/attachments.