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

    DFINER UROLOGICAL CATHETER

    K Number: K013360 · Decision Feb 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    DFINER UROLOGICAL CATHETER
    K Number
    K013360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neoseed Technology,Llc
    Date Received
    October 10, 2001
    Decision Date
    February 20, 2002
    Product Code
    FGI
    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
    FGI Catheter, Urethrographic, Male

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