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Tracheal Tube Stylet

by Sims Surgical, Inc.

510(k) K902180

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK902180 Date19 Jul 1990ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1016-04 FDA Unclassified (pre-2012) initiated 19 May 2004 on shared 510(k) K902180
    • Terminated Z-1017-04 FDA Unclassified (pre-2012) initiated 19 May 2004 on shared 510(k) K902180

    Incompatible products may cause potential trachea trauma

    • Terminated Z-0572-04 FDA Unclassified (pre-2012) initiated 26 Jan 2004

    Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr

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  • Withdrawn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
BSR
Device Class
Class I
Regulation
21 CFR Part 868.5790
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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