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

    FemaSeed Intratubal Insemination

    K Number: K231730 · Decision Sep 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    52
    Applicant Total
    9
    Review Days
    101

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    Basic Information

    Device Name
    FemaSeed Intratubal Insemination
    K Number
    K231730
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6110
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Femasys, Inc.
    Date Received
    June 13, 2023
    Decision Date
    September 22, 2023
    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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