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Found 12 results
510(k) Data Aggregation
K Number
K233361Device Name
Sunny Cup and Applicator
Manufacturer
Menstrual Mates
Date Cleared
2024-06-21
(266 days)
Product Code
HHE
Regulation Number
884.5400Why did this record match?
Product Code :
HHE
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
K140626Device Name
MELUNA CLASSIC/SPORT MENSTRUAL CUP
Manufacturer
MELUNA
Date Cleared
2014-07-10
(121 days)
Product Code
HHE
Regulation Number
884.5400Why did this record match?
Product Code :
HHE
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
K121857Device Name
FEMMYCYCLE
Manufacturer
FEMCAP INCORPORATED
Date Cleared
2012-11-15
(142 days)
Product Code
HHE
Regulation Number
884.5400Why did this record match?
Product Code :
HHE
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
K120107Device Name
SCKOONCUP
Manufacturer
SCKOON INC.
Date Cleared
2012-09-18
(249 days)
Product Code
HHE
Regulation Number
884.5400Why did this record match?
Product Code :
HHE
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
K112165Device Name
RHEA CUP
Manufacturer
APEX MEDICAL TECHNOLOGIES, INC.
Date Cleared
2012-05-24
(301 days)
Product Code
HHE
Regulation Number
884.5400Why did this record match?
Product Code :
HHE
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
K092985Device Name
BELLECUP
Manufacturer
LIBRETTE, INC
Date Cleared
2010-06-28
(273 days)
Product Code
HHE
Regulation Number
884.5400Why did this record match?
Product Code :
HHE
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
K091754Device Name
LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
Manufacturer
LUNE GROUP LTD.
Date Cleared
2009-11-13
(150 days)
Product Code
HHE
Regulation Number
884.5400Why did this record match?
Product Code :
HHE
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
K070965Device Name
ALICIA MENSTRUAL CUP
Manufacturer
ALICIA INTERNATIONAL PTY LTD.
Date Cleared
2008-03-05
(335 days)
Product Code
HHE
Regulation Number
884.5400Why did this record match?
Product Code :
HHE
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
K060852Device Name
MOONCUP
Manufacturer
MOONCUP LIMITED
Date Cleared
2006-12-26
(273 days)
Product Code
HHE
Regulation Number
884.5400Why did this record match?
Product Code :
HHE
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
K040335Device Name
MOONCUP, STYLE A & B
Manufacturer
MOONCUP LLC
Date Cleared
2005-03-30
(413 days)
Product Code
HHE
Regulation Number
884.5400Why did this record match?
Product Code :
HHE
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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