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510(k) Data Aggregation

    K Number
    K050650
    Device Name
    NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Date Cleared
    2005-05-16

    (63 days)

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

    CYTYC SURGICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or incision.
    Device Description
    The NovaCyte Micro endoscope is a semi-rigid fiberscope intended for limited reuse (not to exceed 10 procedures) and is provided non-sterile. The NovaCyte Micro endoscope must be sterilized prior to use. Refer to the Handling, Cleaning and Sterilization instructions. The NovaCyte Accessory Pack is comprised of a solid obturator (dilator) and an Introducer (Cannula). It is intended for single use and is provided sterile.
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