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Lma Stonebreaker Device; Probe Size 1.0mm, 1.6mm, 2.0mm

by The Laryngeal Mask Co., Ltd.

510(k) K062475

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 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 NumberK062475 Date9 May 2007ClearedStatusActive

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-1593-2018 FDA Class II initiated 31 Jan 2018
    • Terminated Z-1592-2018 FDA Class II initiated 31 Jan 2018
    • Terminated Z-1596-2018 FDA Class II initiated 31 Jan 2018
    • Terminated Z-1591-2018 FDA Class II initiated 31 Jan 2018
    • Terminated Z-1594-2018 FDA Class II initiated 31 Jan 2018
    • Terminated Z-1595-2018 FDA Class II initiated 31 Jan 2018
    • Terminated Z-1590-2018 FDA Class II initiated 31 Jan 2018

    The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

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  • Withdrawn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
FFK
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 876.4480
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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