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

    Kahook Dual Blade Glide (KDB Glide)

    K Number: K220891 · Decision May 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    12
    Review Days
    781

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    Basic Information

    Device Name
    Kahook Dual Blade Glide (KDB Glide)
    K Number
    K220891
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    New World Medical, Inc.
    Date Received
    March 28, 2022
    Decision Date
    May 17, 2024
    Product Code
    QUQ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QUQ Knife, Intraocular Pressure Lowering

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