BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    hekaDrill

    K Number: K193630 · Decision Apr 9, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    470

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    Basic Information

    Device Name
    hekaDrill
    K Number
    K193630
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4360
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zethon, Ltd.
    Date Received
    December 26, 2019
    Decision Date
    April 9, 2021
    Product Code
    HBC
    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
    HBC Motor, Drill, Electric

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    Other Clearances by Zethon, Ltd.

    K Number Device Name
    K233958 hekaDrill