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

    NEURO CHECK DEVICE WITH IO-FLEX WIRE

    K Number: K110696 · Decision Jul 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    10
    Review Days
    115

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    Basic Information

    Device Name
    NEURO CHECK DEVICE WITH IO-FLEX WIRE
    K Number
    K110696
    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
    Baxano, Inc.
    Date Received
    March 14, 2011
    Decision Date
    July 7, 2011
    Product Code
    ETN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETN Stimulator, Nerve

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    Other Clearances by Baxano, Inc.

    K Number Device Name
    K113073 IO-TOME DEVICE
    K113533 NEURO CHECK DEVICE WITH IO-FLEX WIRE
    K102594 IO-FLEX CATHETER
    K100958 MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
    K092729 BAXANO NEURO CHECK DEVICE
    K081742 BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
    K080494 BAXANO ULTRA LOW PROFILE RONGEUR
    K063231 MICROBLADE SHAVER AND ACCESSORIES
    K062711 ULTRA LOW PROFILE RONGEUR