BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FERTILIGENT SLOW RELEASE IUI CATHETER KIT

    K Number: K141666 · Decision Feb 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    225

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    Basic Information

    Device Name
    FERTILIGENT SLOW RELEASE IUI CATHETER KIT
    K Number
    K141666
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6110
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fertiligent, Ltd.
    Date Received
    June 23, 2014
    Decision Date
    February 3, 2015
    Product Code
    MQF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQF Catheter, Assisted Reproduction

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    Other Clearances by Fertiligent, Ltd.

    K Number Device Name
    K092579 INTRAUTERINE INSEMINATION (IUI) CATHETER