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Silk Nonabsorbable Surgical Sutures, USP

by Arc Medical Supplies (Beijing) Co, Ltd.

510(k) K000541

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 NumberK000541 Date28 Apr 2000ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

This device is a nonabsorbable suture made from silk, classified under FDA nomenclature as a suture, nonabsorbable, silk. Silk sutures are used for tissue approximation and ligation in surgical procedures, providing durable closure due to their resistance to degradation by bodily fluids.

The sutures are supplied in sterile, single-use packaging and are intended for use in general and plastic surgery settings. They are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance (K000541) as substantially equivalent to predicate devices. Multiple needle and suture sizes are available, adhering to USP standards for surgical applications.

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