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510(k) Data Aggregation

    K Number
    K153701
    Device Name
    ULYSS Multi View Sinuscope
    Manufacturer
    SOPRO-COMEG GMBH
    Date Cleared
    2016-09-09

    (261 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOPRO-COMEG GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULYSS Multi View Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
    Device Description
    The ULYSS Multi View Sinuscope is a 4.3 mm rigid endoscope. The sinuscope is intended for visualization only and does not include operative channels. Instruments do not go through nor come in contact with the scope. The handle part of the ULYSS Multi View Sinuscope incorporates two rotating dials that permit continuous adjustment of the direction of view from 10° to 100° by means of small magnets incorporated into the sinuscope body; 340° rotation of the outer tube (from -170° to +170°). The sinuscope is provided with a rod lens system to transmit images and bundled optical fibers to transmit light from an external light source to illuminate the visual field. A light guide connector is provided for connection to an Olympus®, Storz® or Wolf® light cable by means of an appropriate adapter. The endoscope is also provided with an eyepiece that is compatible with a standard camera coupler. The ULYSS Multi View Sinuscope is a reusable device and must be cleaned and sterilized before use.
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