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

    Koala Intrauterine Pressure Catheter (IPC-5000E)

    K Number: K250897 · Decision May 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    8
    Applicant Total
    9
    Review Days
    58

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    Basic Information

    Device Name
    Koala Intrauterine Pressure Catheter (IPC-5000E)
    K Number
    K250897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Innovations, LLC
    Date Received
    March 25, 2025
    Decision Date
    May 22, 2025
    Product Code
    HFN
    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
    HFN Transducer, Pressure, Intrauterine

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