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

    NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)

    K Number: K231580 · Decision Aug 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    94
    Applicant Total
    6
    Review Days
    91

    Basic Information

    Device Name
    NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
    K Number
    K231580
    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
    Medtronic Xomed, Inc.
    Date Received
    May 31, 2023
    Decision Date
    August 30, 2023
    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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