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510(k) Data Aggregation

    K Number
    K212774
    Device Name
    VenSure LightGuide
    Manufacturer
    Intersect ENT
    Date Cleared
    2022-02-04

    (156 days)

    Product Code
    LRC
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    Intersect ENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VenSure™ LightGuide is used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.
    Device Description
    VenSure™ LightGuide is a sterile, single-use device designed to emit light from the distal end. The device is an accessory to the VenSure™ Balloon device and used to locate, illuminate within and transilluminate across nasal and sinus structures. The device consists of a flexible light fiber, a protective sheath and an integrated battery-powered LED light source. When activated, the light fiber will emit red light from the distal tip for two (2) hours. It has a fiber nominal working length of 20mm (0.79 inch) with an outer diameter of 0.5mm (0.02 inch). The VenSure™ LightGuide is packaged separately.
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