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510(k) Data Aggregation
K Number
K140186Device Name
THE STORK OTC
Manufacturer
Date Cleared
2014-07-11
(168 days)
Product Code
Regulation Number
884.5250Why did this record match?
Applicant Name (Manufacturer) :
RINOVUM WOMEN'S HEALTH, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stork® OTC 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 Stork® OTC contains a cervical cap inside a condom-like silicone sheath. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork® OTC should be used during the ovulatory phase of the menstrual cycle. The Stork® OTC Cervical Cap should not be left in place for longer than six hours.
Device Description
The Stork® OTC package includes: one Instructions for Use, one Conceptacle® and one plastic applicator. Once the couple has decided to attempt to become pregnant, the Stork® OTC Conception System Instruction for Use recommends using the device during female's most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle®, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle® from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cap is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervix. When the cervical cap is loaded onto the applicator (while it is still outside of the body), the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intra-vaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.
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