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Nonabsorbable Silk Surgical Suture

by United States Surgical, A Division of Tyco Healthc

510(k) K904891

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK904891 Date14 Nov 1990DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Nonabsorbable Silk Surgical Suture (Second Source)
510(k) Number
FDA Product Code
GAP
Device Class
Class II
Regulation
21 CFR Part 878.5030
Advisory Committee
General, Plastic Surgery
FDA Decision
SN

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Nonabsorbable silk surgical suture is a sterile, flexible multifilament thread used for general and plastic surgery procedures. It is a Class II device classified as Suture, Nonabsorbable, Silk with product code GAP.

The device is supplied sterile and is intended for single use. It is not indicated for MRI use. The device is authorized under FDA 510(k) clearance K904891 and is subject to special controls.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Nonabsorbable Silk Surgical Suture used for?

    This suture is a sterile, flexible multifilament thread designed for general and plastic surgery procedures. It provides reliable tissue approximation and wound closure in these surgical applications.

  • Is the Nonabsorbable Silk Surgical Suture supplied sterile?

    Yes, the device is supplied in a sterile condition to maintain aseptic technique during surgical procedures. This sterility is essential to prevent infection at the surgical site.

  • Can the Nonabsorbable Silk Surgical Suture be reused?

    No, this suture is intended for single use only. Reusing sutures poses infection risks and may compromise the integrity of the suture material, potentially leading to poor wound healing or other complications.

  • What is the regulatory status of this suture?

    The device is authorized under FDA 510(k) clearance K904891 and is classified as a Class II device with product code GAP. It is subject to special controls as part of its regulatory pathway.