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

    Affirm 400

    K Number: K251286 · Decision Jan 21, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    271

    Basic Information

    Device Name
    Affirm 400
    K Number
    K251286
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
    Date Received
    April 25, 2025
    Decision Date
    January 21, 2026
    Product Code
    QFX
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QFX Diagnostic Neurosurgical Microscope Filter

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