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510(k) Data Aggregation

    K Number
    K222969
    Device Name
    FERTI-LILY Conception Cup
    Manufacturer
    Date Cleared
    2023-06-23

    (269 days)

    Product Code
    Regulation Number
    884.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rosesta Medical BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FERTI.LILY Conception Cup is indicated for over-the-counter home use. It is for couples who have been unable to conceive naturally and who have received a diagnosis of low sperm immobility or unfavorable vaginal environment. After intercourse, the FERTI.LILY Conception Cup is placed around the cervix. It retains semen near the cervical os (the passage between the vaginal cavity and the uterus) as an aid to conception. The FERTI.LIL Y Conception Cup should be used during the ovulatory phase of the menstrual cycle. The FERTI.LILY Conception Cup should not be left in place for longer than one hour.
    Device Description
    The FERTI.LILY Conception Cup is a non-sterile, silicone, over-the-counter (OTC) device for use by couples as an aid to conception that have been unable to get pregnant naturally due to low sperm count, low sperm motility, or an unfavorable vaginal environment. After intercourse, the device is placed in the vagina, the cup-like receptable is deployed using an integrated deployment cord, and the device is positioned over the cervix to physically situate semen near the cervical os. The FERTI.LIL Y Conception Cup can be left in the vagina for a maximum duration of one hour. The FERTI.LILY Conception Cup includes a stem to assist with removal from the vagina.
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