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

    NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

    K Number: K180542 · Decision Aug 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    174

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    Basic Information

    Device Name
    NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe
    K Number
    K180542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Endo Surgical Tech,
    Date Received
    March 1, 2018
    Decision Date
    August 22, 2018
    Product Code
    PDQ
    Advisory Committee
    Ear, Nose, Throat
    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
    PDQ Neurosurgical Nerve Locator

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    Other Clearances by Boston Endo Surgical Tech,

    K Number Device Name
    K182662 NAV PAK Needle, NIM NAV PAK Needle