← Product Code [GAQ](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ) · K930992

# FLEXON AND STAINLESS STEEL SUTURES (K930992)

_American Cyanamid Co. · GAQ · Dec 17, 1993 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K930992

## Device Facts

- **Applicant:** American Cyanamid Co.
- **Product Code:** [GAQ](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ.md)
- **Decision Date:** Dec 17, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4495
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

## Special Controls

*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 of this chapter subject to the limitations in § 878.9. 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) for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K930992](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAQ/K930992)

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