BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Arisure® Closed Male Luer with Spike Adapter (YM060)

    K Number: K240761 · Decision Mar 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    8
    Review Days
    366

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    Basic Information

    Device Name
    Arisure® Closed Male Luer with Spike Adapter (YM060)
    K Number
    K240761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Yukon Medical, LLC
    Date Received
    March 20, 2024
    Decision Date
    March 21, 2025
    Product Code
    LHI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by Yukon Medical, LLC

    K Number Device Name
    K243486 SmartSiteTM Vented Vial Access Device
    K201422 Arisure Closed System Drug Transfer Device (CSTD)
    K151963 SmartSite Vented Vial Access Device
    K132863 SMARTSITE VIALSHIELD
    K122265 VIALOK SINGLE VIAL ACCESS DEVICE VENTED
    K121182 VIALOK NON-VENTED
    K120799 ARISURE NEUTRAL VALVE