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

    Transvaginal Access Platform

    K Number: K191294 · Decision Sep 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    17
    Applicant Total
    45
    Review Days
    115

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    Basic Information

    Device Name
    Transvaginal Access Platform
    K Number
    K191294
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1640
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Medical Resources Corp.
    Date Received
    May 14, 2019
    Decision Date
    September 6, 2019
    Product Code
    HEW
    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
    HEW Culdoscope (And Accessories)

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