LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K120107
    Device Name
    SCKOONCUP
    Manufacturer
    SCKOON INC.
    Date Cleared
    2012-09-18

    (249 days)

    Product Code
    HHE
    Regulation Number
    884.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCKOON INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SckoonCup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
    Device Description
    SckoonCup is a soft, small silicone menstrual cup that is placed internally in the vagina. The SckoonCup is reusable and it holds menstrual flow instead of absorbing. It may remain in the body up to 12 hours. It is available in two sizes: Size 1: Small-Women who have never given birth vaginally; Capacity 23ml Size 2: Large-Women who have given birth vaginally; Capacity 30 ml Material: SckoonCup menstrual cup is manufactured from a soft silicone elastomer.
    Ask a Question

    Page 1 of 1