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

    EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER

    K Number: K041416 · Decision Jul 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    4
    Applicant Total
    5
    Review Days
    36

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    Basic Information

    Device Name
    EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER
    K Number
    K041416
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Deroyal
    Date Received
    May 27, 2004
    Decision Date
    July 2, 2004
    Product Code
    EYC
    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
    EYC Catheter, Upper Urinary Tract

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    K030908 DEROYAL SURGICAL DRAPES BACKTABLE COVER
    K020753 DEROYAL SURGICAL, UMBILICUP