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

    MENTOR SELF-CATH PLUS

    K Number: K003784 · Decision Mar 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    61
    Review Days
    88

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    Basic Information

    Device Name
    MENTOR SELF-CATH PLUS
    K Number
    K003784
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mentor Corp.
    Date Received
    December 7, 2000
    Decision Date
    March 5, 2001
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

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