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

    NEOGUIDE ENDOSCOPY SYSTEM

    K Number: K070622 · Decision Aug 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    108
    Applicant Total
    2
    Review Days
    161

    Basic Information

    Device Name
    NEOGUIDE ENDOSCOPY SYSTEM
    K Number
    K070622
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NEOGUIDE SYSTEMS, INC.
    Date Received
    March 6, 2007
    Decision Date
    August 14, 2007
    Product Code
    FDF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    FDF Colonoscope And Accessories, Flexible/Rigid

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    Other Clearances by NEOGUIDE SYSTEMS, INC.

    K Number Device Name
    K052930 NAVIGATOR ENDOSCOPY SYSTEM