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Sofsilk Suture

by United States Surgical, A Division of Tyco Healthc 2 variants

510(k) K980124

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 NumberK980124 Date27 Mar 1998ClearedStatusActive

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  • Withdrawn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)

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, 22 Sep 2026

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

Sofsilk Suture is a sterile, non‑absorbable, flexible multifilament silk surgical suture composed of the protein fibroin derived from the domesticated silkworm Bombyx mori. The suture is intended for soft‑tissue approximation in general and plastic surgery procedures.

The device is classified as a Class II medical device and received FDA 510(k) clearance (K980124) on 27 March 1998 under product code GAP. It is supplied sterile, intended for single‑use application, and is identified by the manufacturer United States Surgical, a division of Tyco Healthc. No specific size or MRI safety information is provided in the available data.

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