BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Qlicksmart BladeFlask UNIVERSAL

    K Number: K213274 · Decision Jun 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    1
    Review Days
    265

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    Basic Information

    Device Name
    Qlicksmart BladeFlask UNIVERSAL
    K Number
    K213274
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qlicksmart Pty , Ltd.
    Date Received
    September 30, 2021
    Decision Date
    June 22, 2022
    Product Code
    MMK
    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
    MMK Container, Sharps

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