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

    GelPOINT Transvaginal Access Platform

    K Number: K143308 · Decision Oct 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    17
    Applicant Total
    58
    Review Days
    329

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    Basic Information

    Device Name
    GelPOINT Transvaginal Access Platform
    K Number
    K143308
    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
    Date Received
    November 18, 2014
    Decision Date
    October 13, 2015
    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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