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) → PTX — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

# PTX · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

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

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

## Overview

- **Product Code:** PTX
- **Device Name:** Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
- **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 (0 of 0)

_No cleared devices on record._

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

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