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

    LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES

    K Number: K111014 · Decision Jul 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    17
    Applicant Total
    6
    Review Days
    459

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    Basic Information

    Device Name
    LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
    K Number
    K111014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1640
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lsi Solutions, Inc.
    Date Received
    April 11, 2011
    Decision Date
    July 13, 2012
    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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