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

    ANAL RECTAL OVERTUBE

    K Number: K131598 · Decision Feb 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    94
    Review Days
    268

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    Basic Information

    Device Name
    ANAL RECTAL OVERTUBE
    K Number
    K131598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    United States Endoscopy Group, Inc.
    Date Received
    June 3, 2013
    Decision Date
    February 26, 2014
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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