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

    MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM

    K Number: K111480 · Decision Apr 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    3
    Review Days
    313

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    Basic Information

    Device Name
    MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
    K Number
    K111480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Technology Delivery Systems, Inc.
    Date Received
    May 27, 2011
    Decision Date
    April 4, 2012
    Product Code
    FGB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FGB Ureteroscope And Accessories, Flexible/Rigid

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    Other Clearances by Technology Delivery Systems, Inc.

    K Number Device Name
    K062725 MAXIFLEX-SEMI FLEX SCOPE
    K013300 MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM