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

    SILICONE FOLEY CATHETER

    K Number: K951106 · Decision May 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    104
    Review Days
    76

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    Basic Information

    Device Name
    SILICONE FOLEY CATHETER
    K Number
    K951106
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Urological, Inc.
    Date Received
    March 10, 1995
    Decision Date
    May 25, 1995
    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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