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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
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    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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    K Number
    K140626
    Device Name
    MELUNA CLASSIC/SPORT MENSTRUAL CUP
    Manufacturer
    MELUNA
    Date Cleared
    2014-07-10

    (121 days)

    Product Code
    HHE
    Regulation Number
    884.5400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MeLuna Menstrual Cup 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
    The MeLuna Menstrual Cup is a soft small TPE (Thermoplastic elastomer) menstrual cup that is placed internally in the vagina. The MeLuna is reusable and holds menstrual flow instead of absorbing it. It is available in two size classifications: Standard and Shorty, with cup diameters the same for both Shorty and Regular, but cup capacity and cup length varying between the two classifications. The cups are available in two different firmness levels referred to as Classic or Sport. The Classic material has a shore rating of 40; the firmer Sport model has a shore rating of 50.
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    K Number
    K121857
    Device Name
    FEMMYCYCLE
    Manufacturer
    FEMCAP INCORPORATED
    Date Cleared
    2012-11-15

    (142 days)

    Product Code
    HHE
    Regulation Number
    884.5400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemmyCycle® 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
    Not Found
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    K Number
    K120107
    Device Name
    SCKOONCUP
    Manufacturer
    SCKOON INC.
    Date Cleared
    2012-09-18

    (249 days)

    Product Code
    HHE
    Regulation Number
    884.5400
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    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.
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    K Number
    K112165
    Device Name
    RHEA CUP
    Manufacturer
    APEX MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2012-05-24

    (301 days)

    Product Code
    HHE
    Regulation Number
    884.5400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rhea Cup 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
    The Rhea Cup is a reusable menstrual cup placed in the vagina to collect blood and cervical debris that is extruded from the uterus via the cervix during menstruation. The Rhea Cup will be made in two model sizes to allow for the variability of the female vagina and menstrual flow due to normal differences between women as well as the effects of childbirth. Model 1 holds approximately 25ml of fluid and is for women who have never given birth vaginally. Model 2 holds approximately 30ml of fluid and is for women who have given birth vaginally. The Rhea Cup is made of a flexible silicone elastomer which allows for easy insertion and a comfortable fit in the body. This material is durable and allows the cup to be used during many menstrual cycles. The Rhea Cup is comprised of a body, which acts as a receptacle for fluid and a ribbed tail attached at the base of the body, providing support when removing the cup from the vagina. The Rhea Cup is made of a silicone elastomer, which has been cleared by the FDA for use in the BelleCup (K092985) predicate device.
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    K Number
    K092985
    Device Name
    BELLECUP
    Manufacturer
    LIBRETTE, INC
    Date Cleared
    2010-06-28

    (273 days)

    Product Code
    HHE
    Regulation Number
    884.5400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BelleCup 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
    Trade Name: BelleCup Common Name: Menstrual Cup Device Class: II Review Panel: Obstetrics/Gynecology Product Code: HHE Regulation Number: 21 CFR 884.5400 The device is manufactured from a single component, LIM6040-D2 silicone elastomer, which is compliant with 21 CFR 177.2600 (Rubber articles intended for repeated use). The BelleCup is not supplied sterile.
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    K Number
    K091754
    Device Name
    LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
    Manufacturer
    LUNE GROUP LTD.
    Date Cleared
    2009-11-13

    (150 days)

    Product Code
    HHE
    Regulation Number
    884.5400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lunette Menstrual Cup (Models 1, 2) 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
    The Lunette™ menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available in two sizes: - Size 1 for light flow and women who have not had intercourse (diameter of 41 . mm, a height of 73 mm, and a volume of 25 ml) - . Size 2 for heavy flow (diameter of 45 mm, a height of 78 mm, and a volume of 30 ml) The cup remains entirely within the vagina and does not touch the cervix but the stem remains outside the body to ensure retrieval of the cup. The user's guide provides information about how to use and care for the Lunette™ menstrual cup (Attachment 5). Lunette™ menstrual cup is a re-useable internal receptacle that is placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation. Lunette™ Menstrual Cup is positioned in the lower portion of the vagina. The cup does not touch the cervix or interfere with the menstrual flow through it.
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    K Number
    K070965
    Device Name
    ALICIA MENSTRUAL CUP
    Manufacturer
    ALICIA INTERNATIONAL PTY LTD.
    Date Cleared
    2008-03-05

    (335 days)

    Product Code
    HHE
    Regulation Number
    884.5400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alicia 100 Menstrual Cup / Models 99ALXS, 100ALSM, 101ALMD, 102ALLG 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
    The Alicia™ menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available four sizes: · L size: 102ALLG; for larger built women that have had children. · M size: 101ALMD; for women who have had vaginal childbirth or C-Section; and for women who are over 30 years old and never had childbirth. S size: 100ALSM; for women under 30 years old who have never had childbirth or C-Section. · XS size: 99ALXS; for teenagers and very small framed women. The cup remains entirely within the vagina and does not tough the cervix but the stem remains outside the body to ensure retrieval of the cup. The Alicia™ menstrual cup is manufactured from a soft silicone elastomer.
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    K Number
    K060852
    Device Name
    MOONCUP
    Manufacturer
    MOONCUP LIMITED
    Date Cleared
    2006-12-26

    (273 days)

    Product Code
    HHE
    Regulation Number
    884.5400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mooncup 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
    Not Found
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    K Number
    K040335
    Device Name
    MOONCUP, STYLE A & B
    Manufacturer
    MOONCUP LLC
    Date Cleared
    2005-03-30

    (413 days)

    Product Code
    HHE
    Regulation Number
    884.5400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MoonCup® 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
    The MoonCup® menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available in two sizes: Style A - After childbirth; Style B Before childbirth and/or C-section. The cup remains entirely within the vagina and does not touch the cervix but the stem remains outside the body to ensure retrieval of the cup.
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