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510(k) Data Aggregation

    K Number
    K132423
    Device Name
    THE GYNOCULAR
    Manufacturer
    Date Cleared
    2014-04-08

    (246 days)

    Product Code
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNIUS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gynocular is intended to provide magnified visualization of the tissues of the vagina, cervix and external genitalia. It is used to evaluate these tissues and select areas for biopsy.
    Device Description
    The Gynocular is a hand-held, colposcope, which provides a magnified visualization of the tissues of the cervix, vagina, vulva and anogential area. It is used to evaluate these tissues and select areas for biopsy, without contacting the patient. The user is a medical physician, or a trained colposcopist. The Gynocular is a colposcope with similar specifications to traditional colposcopes. The Gynocular has a 300 mm focal distance, 3-magnifications: 5x, 8x, and 12x. It is a handheld device that comes with a tripod-mounting clip that screws into a standard tripod enabling the medical professional to also perform colposcopy hands-free mode for ease of biopsy. The Gynocular uses high intensity LEDs for illumination, has a green filter, and is powered by a rechargeable lithium-ion battery. We also provide a charging base for the Gynocular.
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