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

    evoDrill Cranial Perforator

    K Number: K231403 · Decision Mar 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    296

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    Basic Information

    Device Name
    evoDrill Cranial Perforator
    K Number
    K231403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4305
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Evonos GmbH & Co. KG
    Date Received
    May 15, 2023
    Decision Date
    March 6, 2024
    Product Code
    HBF
    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
    HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)

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