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510(k) Data Aggregation

    K Number
    K130046
    Device Name
    CLEARSPEC SINGLE USE VAGINAL SPECULUM
    Manufacturer
    CLEARSPEC LLC
    Date Cleared
    2013-08-06

    (210 days)

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

    CLEARSPEC LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearSpec Single-Use Vaginal Speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.
    Device Description
    The ClearSpec Single Use Vaginal Speculum is a disposable vaginal speculum constructed of polystyrene, used to dilate the vagina and expose the interior of the vagina and exterior of the cervix, and employs a unique flexible polyurethane sheath that is designed to assist in keeping the lateral walls of the vagina clear of the viewing area. The vaginal speculum can be used with or without an illuminator. The ClearSpec® Single Use Vaginal Speculum is made available in various sizes from extra small to large to accommodate vagina cavity size.
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