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Cautery Tip Cleaner, Model 30500

by Xodus Medical, Inc.

510(k) K053433

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 NumberK053433 Date19 Jan 2006ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0149-2020 FDA Class II initiated 19 Sep 2019
    • Terminated Z-0150-2020 FDA Class II initiated 19 Sep 2019
    • Terminated Z-0151-2020 FDA Class II initiated 19 Sep 2019

    The sterile barrier of some devices may have been affected

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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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