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CUSA Clarity Ultrasonic Surgical Aspirator System

by Integra Lifesciences Corporation 7 variants

510(k) K182809

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

42 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 NumberK182809 Date7 Dec 2018ClearedStatusActive

Recalls

42 recalls · FDA

  • 41 recalls, same reason

    • Terminated Z-0634-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0633-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0637-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0614-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0641-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0653-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0622-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0643-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0625-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0620-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0645-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0631-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0624-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0636-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0648-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0650-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0621-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0619-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0628-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0651-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0618-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0647-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0649-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0616-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0640-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0644-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0617-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0646-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0630-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0629-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0652-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0615-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0635-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0632-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0638-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0639-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0623-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0627-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0626-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0642-2020 FDA Class II initiated 21 Oct 2019
    • Terminated Z-0654-2020 FDA Class II initiated 21 Oct 2019

    The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

    • Terminated Z-0613-2020 FDA Class II initiated 21 Oct 2019

    The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operator s manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

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
LFL
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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