BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Velocity Alpha MR High Speed Surgical Drill System

    K Number: K253772 · Decision Mar 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    26
    Applicant Total
    4
    Review Days
    100

    Basic Information

    Device Name
    Velocity Alpha MR High Speed Surgical Drill System
    K Number
    K253772
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4370
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adeor Medical AG
    Date Received
    November 26, 2025
    Decision Date
    March 6, 2026
    Product Code
    HBB
    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
    HBB Motor, Drill, Pneumatic

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