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

    SurgeoBite

    K Number: K172978 · Decision Dec 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    86

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    Basic Information

    Device Name
    SurgeoBite
    K Number
    K172978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5070
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgovations, LLC
    Date Received
    September 27, 2017
    Decision Date
    December 22, 2017
    Product Code
    JXL
    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
    JXL Block, Bite

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