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510(k) Data Aggregation

    K Number
    K233361
    Device Name
    Sunny Cup and Applicator
    Manufacturer
    Menstrual Mates
    Date Cleared
    2024-06-21

    (266 days)

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

    Menstrual Mates

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sunny Cup and Applicator is a receptacle placed in the vagina to collect blood and cellular debris that is exuded from the uterus via the cervix during menstruation.
    Device Description
    The Sunny Cup and Applicator is an over the counter (OTC) medical device consisting of a reusable silicone menstrual cup with a lubricious coating and a reusable applicator with a nylon body and a thermoplastic polyurethane (TPU) tip with a lubricious coating. The Sunny Cup is a soft receptacle designed for placement within the vaginal canal to hold up to 25 mL of menstrual fluid and can remain within the body for up to 12 hours. The Sunny Cup is also designed with grip lines and a stem on the distal end to allow for easy location and manipulation of the Sunny Cup during removal. The Applicator component enables the insertion process for the user and consists of a barrel, a pusher, and a pusher base, functioning similarly to a tampon applicator. For the insertion process, the Sunny Cup is folded and placed in the Applicator barrel. The pusher component is then used to deploy the Cup through the Applicator. The Sunny Cup then unfolds upon deployment to create a seal in the vaginal canal and collect menstrual fluid. After 12 hours, the Sunny Cup is removed manually by squeezing the grip lines to break the seal and pulling the Cup out by the grip lines along the base of the Cup. The Cup component should be cleaned via boiling at the start of each menstrual cycle, and the Cup and Applicator components should be cleaned with warm water and mild, fragrance-free soap between uses. The Sunny Cup and Applicator may be reused by a single patient for up to a year or until discoloration or damage is evident.
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