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

    Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)

    K Number: K191264 · Decision Oct 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    173

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    Basic Information

    Device Name
    Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
    K Number
    K191264
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ujenzi Charitable Trust
    Date Received
    May 10, 2019
    Decision Date
    October 30, 2019
    Product Code
    OQY
    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
    OQY Intrauterine Tamponade Balloon

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