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) → NJU — Suture, Nonabsorbable, Nitinol

# NJU · Suture, Nonabsorbable, Nitinol

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

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

## Overview

- **Product Code:** NJU
- **Device Name:** Suture, Nonabsorbable, Nitinol
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K023372](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NJU/K023372.md) | NON-BIOABSORBABLE STAPLE | Onux Medical, Inc. | Dec 27, 2002 | SESE |
| [K023125](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NJU/K023125.md) | COALESCENT U-CLIP- AND ACCESSORIES | Coalescent Surgical | Dec 18, 2002 | SESE |

## Top Applicants

- Coalescent Surgical — 1 clearance
- Onux Medical, Inc. — 1 clearance

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

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