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Synthetic Absorbable Surgical Suture

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

510(k) K963253

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK963253 Date8 Oct 1996ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2541-2017 FDA Class II initiated 3 May 2017

    Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

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  • Withdrawn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
GAM
Device Class
Class II
Regulation
21 CFR Part 878.4493
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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