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Rusch Endobronchial Tube Sets

by Rusch Intl.

510(k) K951091

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

10 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 NumberK951091 Date8 Jun 1995ClearedStatusActive

Recalls

10 recalls · FDA

  • 9 recalls, same reason

    • Terminated Z-2409-2015 FDA Class II initiated 21 Nov 2014
    • Terminated Z-2414-2015 FDA Class II initiated 21 Nov 2014
    • Terminated Z-2415-2015 FDA Class II initiated 21 Nov 2014
    • Terminated Z-2408-2015 FDA Class II initiated 21 Nov 2014
    • Terminated Z-2407-2015 FDA Class II initiated 21 Nov 2014
    • Terminated Z-2412-2015 FDA Class II initiated 21 Nov 2014
    • Terminated Z-2411-2015 FDA Class II initiated 21 Nov 2014
    • Terminated Z-2413-2015 FDA Class II initiated 21 Nov 2014
    • Terminated Z-2410-2015 FDA Class II initiated 21 Nov 2014

    Customer complaints reporting that the cobb connector detached from the main connector prior to use.

    • Terminated Z-1231-2014 FDA Class II initiated 28 Feb 2014

    The product may fail to achieve seal of right lung due to the cuff inflating to one side

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  • Withdrawn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
BTS
Device Class
Class II
Regulation
21 CFR Part 868.5720
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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