Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K964634
    Device Name
    ANOKRYO
    Date Cleared
    1997-06-06

    (199 days)

    Product Code
    Regulation Number
    876.5450
    Why did this record match?
    Product Code :

    FFP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dilation of the anal sphincter and canal for the relief of hemorrhoidal pain and itching, reduction of bleeding, and promotion of healing of inflamed hemorrhoidal tissues.
    Device Description
    The Anokryo Dilator consists of a narrow tapered shaft approximately 2.75 inch long and 0.5 inch wide. The hollow interior of the shaft is filled with hydroxyethylcellulose solution before the shaft is molded to a flange knob which serves as a handle The shaft and flange are composed of polyethylene. The device is supplied clean and non-sterile in a plastic storage container and a water-soluble lubricant gel. Prior to use, the rod is stored in its container for 1-2 hours and then moistened with the lubricant gel. A maximum low temperature of -15 degrees C is obtained and sustained for 10 minutes. The device is easily cleaned with detergent and water and stored in its container for reuse.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1