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

    DIRECTVISION GUIDE SYSTEM

    K Number: K091600 · Decision Aug 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    83

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    Basic Information

    Device Name
    DIRECTVISION GUIDE SYSTEM
    K Number
    K091600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Percuvision, LLC
    Date Received
    June 3, 2009
    Decision Date
    August 25, 2009
    Product Code
    FGC
    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
    FGC Urethroscope

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