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

    PEDIGUARD NERVE DETECTOR SYSTEM

    K Number: K123390 · Decision Aug 8, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    34
    Applicant Total
    6
    Review Days
    279

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    Basic Information

    Device Name
    PEDIGUARD NERVE DETECTOR SYSTEM
    K Number
    K123390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Spineguard S.A.
    Date Received
    November 2, 2012
    Decision Date
    August 8, 2013
    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 Spineguard S.A.

    K Number Device Name
    K220160 PediGuard Threaded
    K201454 DSG Connect Technology
    K162884 SpineGuard DSG Zavation Screw System
    K152747 DSG Threaded Drill System
    K143159 Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS