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

    Fuse Gastroscopy System

    K Number: K152182 · Decision Dec 10, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    68
    Applicant Total
    1
    Review Days
    127

    Basic Information

    Device Name
    Fuse Gastroscopy System
    K Number
    K152182
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ENDOCHOICE INC.
    Date Received
    August 5, 2015
    Decision Date
    December 10, 2015
    Product Code
    FDS
    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
    FDS Gastroscope And Accessories, Flexible/Rigid

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