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X-Ray Detectable Cotton Balls

by American Silk Sutures, Inc.

510(k) K854714

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K854714; other models may be affected

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 NumberK854714 Date17 Dec 1985ClearedStatusActive

Recalls

37 recalls · 1 ongoing · FDA

    • Ongoing Z-0287-2025 FDA Class II initiated 18 Sep 2024 on shared 510(k) K854714

    Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.

  • 36 recalls, same reason

    • Terminated Z-1735-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1757-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1758-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1731-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1750-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1732-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1748-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1734-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1745-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1736-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1727-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1742-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1755-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1738-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1747-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1759-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1754-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1729-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1744-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1746-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1728-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1737-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1743-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1730-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1756-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1740-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1762-2016 FDA Class II initiated 31 Mar 2016 on shared 510(k) K854714
    • Terminated Z-1749-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1752-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1724-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1733-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1723-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1741-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1760-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1753-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1739-2016 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
GDY
Device Class
Class I
Regulation
21 CFR Part 878.4450
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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