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

    SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE

    K Number: K023902 · Decision Aug 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    2
    Review Days
    271

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    Basic Information

    Device Name
    SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
    K Number
    K023902
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Usgi Medical, Inc.
    Date Received
    November 22, 2002
    Decision Date
    August 20, 2003
    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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    Other Clearances by Usgi Medical, Inc.

    K Number Device Name
    K033954 SHAPE LOCKING ENDOSCOPIC OVERTUBE