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

    Altaviz Intravitreal Syringe

    K Number: K243322 · Decision May 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    3
    Review Days
    198

    Basic Information

    Device Name
    Altaviz Intravitreal Syringe
    K Number
    K243322
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Altaviz, LLC
    Date Received
    October 23, 2024
    Decision Date
    May 9, 2025
    Product Code
    QLY
    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
    QLY Ophthalmic Syringe

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    Other Clearances by Altaviz, LLC

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