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

    Forcyte Autograft Harvest Kit

    K Number: K243407 · Decision Jul 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    1
    Review Days
    270

    Basic Information

    Device Name
    Forcyte Autograft Harvest Kit
    K Number
    K243407
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Forcyte Medical, LLC
    Date Received
    November 1, 2024
    Decision Date
    July 29, 2025
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNW Instrument, Biopsy

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