21 CFR § 888.4580 - Sonic surgical instrument and accessories/attachments.

---
identifier: "/us/cfr/t21/s888.4580"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.4580 - Sonic surgical instrument and accessories/attachments."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.4580"
section_name: "Sonic surgical instrument and accessories/attachments."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "888"
part_name: "ORTHOPEDIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "52 FR 33702, Sept. 4, 1987, unless otherwise noted."
cfr_part: "888"
---


# 888.4580 Sonic surgical instrument and accessories/attachments.

(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.

[52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019]