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510(k) Data Aggregation

    K Number
    K192300
    Device Name
    EnlightenVue Microendoscopy System
    Manufacturer
    Date Cleared
    2020-03-20

    (210 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    EnlightenVue, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The enlightenVue Microendoscopy System is intended for visualization of body cavities, hollow organs, and canals. The surgiVue microendoscope is designed to be introduced through natural body cavities or surgical incisions through introducers, trocars, needles, sheaths, or other devices with lumens having inside diameters larger than the outer diameter of the microendoscope.
    Device Description
    The enlightenVue Microendoscopy System is comprised of the surgiVue microendoscope and surgiTrac laser light source. This system is used to provide imaging capability of internal anatomy for both diagnostic and interventional procedures. The small laser light source focuses light onto a small fiber in the form of white light. The surgiTrac interfaces with the disposable surgiVue microendoscope and a PC to allow for illumination of the captured image.
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