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Polyester Sponge Pattie

by American Silk Sutures, Inc.

510(k) K862494

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862494 Date30 Jul 1986ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-1810-2016 FDA Class II initiated 31 Mar 2016 on shared 510(k) K862494
    • Terminated Z-1808-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1807-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1809-2016 FDA Class II initiated 31 Mar 2016

    Product packaging defective compromising sterility

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
HBA
Device Class
Class II
Regulation
21 CFR Part 882.4700
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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