BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇿🇦 South Africa

    ELLAVI UBT

    K Number: K230849 · Decision Nov 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    230

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    Basic Information

    Device Name
    ELLAVI UBT
    K Number
    K230849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sinapi Biomedical (Pty) , Ltd.
    Date Received
    March 28, 2023
    Decision Date
    November 13, 2023
    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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