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

    PRIME-XV FreezIS DMSO-Free MD

    K Number: K231804 · Decision Nov 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    142

    Basic Information

    Device Name
    PRIME-XV FreezIS DMSO-Free MD
    K Number
    K231804
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.5885
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Irvine Scientific
    Date Received
    June 20, 2023
    Decision Date
    November 9, 2023
    Product Code
    NDS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NDS Media, Culture, Ex Vivo, Tissue And Cell

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