BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇪 Ireland

    BioHealx Anal Fistula Device

    K Number: DEN240007 · Decision Jul 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    150

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BioHealx Anal Fistula Device
    K Number
    DEN240007
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4835
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Signum Surgical Limited
    Date Received
    February 2, 2024
    Decision Date
    July 1, 2024
    Product Code
    QML
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QML Anal Fistula Closure Device