---
kind: "section"
citation: "21 C.F.R. § 888.4580"
title: "21"
number: "888.4580"
heading: "Sonic surgical instrument and accessories/attachments."
url: "https://uscodex.org/cfr/21/888.4580"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 888.9](/cfr/21/888.9.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

### Amendments

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