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

    Aveta System 2.0

    K Number: K223813 · Decision Aug 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    5
    Review Days
    244

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    Basic Information

    Device Name
    Aveta System 2.0
    K Number
    K223813
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meditrina, Inc.
    Date Received
    December 20, 2022
    Decision Date
    August 21, 2023
    Product Code
    HIH
    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
    HIH Hysteroscope (And Accessories)

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    Other Clearances by Meditrina, Inc.

    K Number Device Name
    K213171 Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
    K192100 Aveta Disposable Hysteroscope
    K191958 Aveta System
    K190372 Aveta System