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510(k) Data Aggregation

    K Number
    K141666
    Device Name
    FERTILIGENT SLOW RELEASE IUI CATHETER KIT
    Manufacturer
    FERTILIGENT, LTD
    Date Cleared
    2015-02-03

    (225 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERTILIGENT, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Delivery of approximately 1ml of sperm into the uterus over 3-4 hours using a controlled release pump.
    Device Description
    The subject device is a balloon catheter for slow release intrauterine insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The subject device is provided with a standard 3 ml syringe, a mechanical actuator, and a leg strap. Sperm is loaded into the syringe, and the syringe is attached to the IUI catheter. The syringe is placed in the mechanical actuator to deliver the sperm over a 3-4 hour period.
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    K Number
    K092579
    Device Name
    INTRAUTERINE INSEMINATION (IUI) CATHETER
    Manufacturer
    FERTILIGENT, LTD
    Date Cleared
    2010-04-02

    (228 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERTILIGENT, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Delivery of approximately 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump.
    Device Description
    The IUI Catheter is a balloon catheter for slow release insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The kit includes a standard BD 3 ml syringe and a mechanical actuator, as well as an ancillary component, a leg strap. Sperm is loaded into the syringe which is attached to the IUI catheter. The syringe is placed in a plastic, spring loaded mechanical actuator to press on the syringe plunger and deliver the sperm over a 3-4 hour period.
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