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510(k) Data Aggregation

    K Number
    K242031
    Device Name
    Béa Applicator (BAP-GB-01)
    Date Cleared
    2025-04-02

    (265 days)

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

    StepOne Fertility Ltd (t/a Béa Fertility)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Béa Applicator is indicated for over-the-counter home use by couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. The Béa Applicator contains a Béa Cervical Cap which is used to contain, deliver, and retain semen near the cervical opening as an aid to conception. The Béa Applicator should be used during the ovulatory phase of the menstrual cycle. The Béa Cervical Cap should not be left in place for longer than 5 hours.
    Device Description
    The Béa Applicator is an 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. The Applicator is provided to the users pre-assembled with the silicone cervical cap and a funnel to guide the semen into the cervical cap. Semen is poured from a sterile semen container into the cervical cap, which is located in the Applicator. The user inserts the Applicator into the vagina and deploys the cervical cap at or near the cervix by turning the handle. The Applicator is removed from the vagina and the cervical cap is left for up to five (5) hours to allow sperm to travel through the cervical canal. The user then removes the cervical cap from the vagina using its attached retrieval string and disposes of it. All components of the Béa Applicator are single-use only. The applicator and cervical cap components are non-sterile, while the semen collection container is provided sterile.
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