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

    Fuse Endoscopic System with FuseBox Processor

    K Number: K160275 · Decision Aug 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    27
    Review Days
    181

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    Basic Information

    Device Name
    Fuse Endoscopic System with FuseBox Processor
    K Number
    K160275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endochoice, Inc.
    Date Received
    February 2, 2016
    Decision Date
    August 1, 2016
    Product Code
    PEA
    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
    PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement

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    Other Clearances by Endochoice, Inc.

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