BEUDAMED
    Product Code: MKN FDA class 3

    Catheter, Balloon, Transcervical

    Unknown

    The Transcervical Balloon Catheter is a catheter with an inflatable balloon designed to be introduced through the cervical canal into the uterus, used for cervical ripening or dilation in preparation for labor induction or intrauterine procedures. As a Class 3 device, it requires Premarket Approval (PMA) because general and special controls are insufficient to assure safety and effectiveness for this indication. No regulation number or medical specialty code is recorded, and it carries no implant or life-sustaining flags.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    MKN
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OB
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting