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510(k) Data Aggregation

    K Number
    K993568
    Device Name
    MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
    Date Cleared
    2000-03-13

    (144 days)

    Product Code
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    MACHIDA ENDOSCOPE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MACHIDA Floxible Neuro-Endoscopes, Model NEU-4/NEU-4L are designed to be introduced into the cranium area through the surgically created orifice for the purpose of the observation, the treatment and the recording by photography.
    Device Description
    Flexible Neuro-Endoscope, NEU-4/4L are mainly desighed for observation and treatment by small instrument which is inserted through the working channel, specifically in the intra-cranium area. The device is mainly constructed with the fiber optic system for imaging and illumination. The device is covered internally by thin stainless spiral plate and outside by a tube so that the flexibility is always maintained. The device is mainly composed of the control grip, insertion tube, deflecting section, internal working channel, light guide cable and the distal end where the objective lens system are incorporated in addition to the fiber optic imaging and illuminating system. All the material specifically those which are in direct contact with human tissue are proven safe for the medical use.
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