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510(k) Data Aggregation

    K Number
    K052420
    Device Name
    G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
    Manufacturer
    Date Cleared
    2006-04-06

    (216 days)

    Product Code
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNOVA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To retract and expose the interior of the vagina during general diagnostic and therapeutic gynecological and obstetric procedures.
    Device Description
    G-SpecTM Articulated Weighted Vaginal Speculum is supplied with single use disposable blades that attached to a 2 pound stainless steel weighted speculum handle. The disposable blades are supplied in three sizes: 9, 11, and 13 centimeters And can be set to three positions relative to the weighted handle: 90, 80, and 70 degrees The disposable blades snap fit into the reusable weighted speculum handle and are discarded after each use. The reusable weighted speculum handle is reusable and may be cleaned and resterilized.
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