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Modification to: Modified Uss Polypropylene Suture

by United States Surgical, A Division of Tyco Healthc

510(k) K050947

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 · Special NumberK050947 Date1 Jun 2005ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2922-2026 FDA Class II initiated 24 Jun 2026

    Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

    • Ongoing Z-1180-2023 FDA Class II initiated 2 Dec 2022

    Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

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  • Withdrawn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
GAW
Device Class
Class II
Regulation
21 CFR Part 878.5010
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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