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510(k) Data Aggregation

    K Number
    K153009
    Device Name
    ULTRA Telescopes
    Date Cleared
    2016-04-05

    (174 days)

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

    **OLYMPUS, WINTER **& IBE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Telescope for endoscopic observation, diagnosis and treatment during nasal endoscopy and sinuscopy.
    Device Description
    The "ULTRA" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The "ULTRA" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The "ULTRA" Telescopes are available with four different directions of view (0°, 30°, 45°, and 70°) to allow use for various applications in accordance with the intended use as submitted with this 510(k). To address surgeon's preferences, the 30°, 45°, and 70° models are available as an inverse version as well (the light guide cable adapter is at the bottom, instead of at the top of the telescope).
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