LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K191052
    Device Name
    HyaloGYN Vaginal Moisturizing Suppositories
    Manufacturer
    Fidia Farmaceutici S.p.A
    Date Cleared
    2020-01-09

    (265 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fidia Farmaceutici S.p.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Hyalo GYN® Vaginal Moisturizing Suppositories are personal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Hyalo GYN® Vaginal Moisturizing Suppositories are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
    Device Description
    Hyalo GYN® Vaginal Moisturizing Suppositories are non-sterile, glyceride-based personal lubricants. The subject lubricant is intended to moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The Hyalo GYN® Vaginal Moisturizing Suppositories are provided in peel-to-open pre-cut strips, in an outer cardboard box with a package insert.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1