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Suture Nonabsorbable Silk

by Surgimetrics International, Ltd.

510(k) K931913

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)SESE Substantially Equivalent · Traditional NumberK931913 Date3 Mar 1994ClearedStatusActive

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  • Withdrawn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
Suture Non-Absorbable Silk
510(k) Number
FDA Product Code
GAP
Device Class
Class II
Regulation
21 CFR Part 878.5030
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

A natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species.

It is supplied as a sterile device, classified as FDA Class 2 under regulation number 878.5030, with product code GAP and clearance type Traditional. The device received 510(k) clearance on March 3, 1994, under K931913, and is indicated for use in general and plastic surgery.

Other devices from Surgimetrics International, Ltd.

Questions

AI-generated answers, 21 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 Suture Non-Absorbable Silk used for?

    This device is indicated for use in general and plastic surgery as a nonabsorbable surgical suture to approximate and ligate tissue during wound closure.

  • How is the Suture Non-Absorbable Silk supplied and sterilized?

    The suture is supplied as a sterile device in multifilament form, composed of the natural protein fibroin derived from domesticated silk, ensuring it is ready for single-use surgical applications.

  • Is the Suture Non-Absorbable Silk reusable or single-use?

    As a sterile surgical suture, this device is intended for single-use only to maintain sterility and prevent cross-contamination; resterilization or reuse is not recommended or supported by its design.

  • What regulatory pathway was used for the Suture Non-Absorbable Silk?

    The device received FDA 510(k) clearance under K931913 on March 3, 1994, based on a determination of substantial equivalence to a predicate device under regulation number 878.5030.

  • What are the key material and classification details of the Suture Non-Absorbable Silk?

    It is a nonabsorbable, sterile, flexible multifilament thread made from the organic protein fibroin, classified as FDA Class 2 with product code GAP, and falls under the medical specialty of general and plastic surgery.