---
kind: "section"
citation: "21 C.F.R. § 878.4495"
title: "21"
number: "878.4495"
heading: "Stainless steel suture."
url: "https://uscodex.org/cfr/21/878.4495"
---

# §878.4495. Stainless steel suture.

- (a) **Identification.** A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.
- (b) **Classification.** Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, 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 [§ 878.9](/cfr/21/878.9.md). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See [§ 878.1(e)](/cfr/21/878.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[65 FR 19836, Apr. 13, 2000, as amended at 68 FR 32984, June 3, 2003; 84 FR 71814, Dec. 30, 2019]

### Authority

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

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[65 FR 19836, Apr. 13, 2000, as amended at 68 FR 32984, June 3, 2003; 84 FR 71814, Dec. 30, 2019]