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

    Hubly Drill (H100)

    K Number: K250815 · Decision Nov 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    64
    Applicant Total
    2
    Review Days
    234

    Basic Information

    Device Name
    Hubly Drill (H100)
    K Number
    K250815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hubly, Inc.
    Date Received
    March 17, 2025
    Decision Date
    November 6, 2025
    Product Code
    HBE
    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
    HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

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