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

    ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

    K Number: K243945 · Decision Apr 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    25
    Review Days
    125

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    Basic Information

    Device Name
    ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
    K Number
    K243945
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SurGenTec, LLC
    Date Received
    December 20, 2024
    Decision Date
    April 24, 2025
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    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
    KNW Instrument, Biopsy

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