Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4495](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4495) → GAO — Suture, Nonabsorbable

# GAO · Suture, Nonabsorbable

_General, Plastic Surgery · 21 CFR 878.4495 · Class 2_

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

## Overview

- **Product Code:** GAO
- **Device Name:** Suture, Nonabsorbable
- **Regulation:** [21 CFR 878.4495](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4495)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K932513](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAO/K932513.md) | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | Alto Development Corp. | Jan 7, 1994 | SESE |
| [K872532](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAO/K872532.md) | AUTO SUTURE STAINLESS STEEL SUTURES* | United States Surgical, A Division of Tyco Healthc | Aug 5, 1987 | SESE |
| [K863034](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAO/K863034.md) | SHARPOINT STAINLESS STEEL SUTURE | Chathamborough Research Group, Inc. | Sep 30, 1986 | SESE |
| [K802248](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAO/K802248.md) | DISARP ORIGINAL | Unoplast A/S | Sep 26, 1980 | SESE |

## Top Applicants

- Alto Development Corp. — 1 clearance
- Chathamborough Research Group, Inc. — 1 clearance
- United States Surgical, A Division of Tyco Healthc — 1 clearance
- Unoplast A/S — 1 clearance

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

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