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

    ENDO FMS UROLOGY

    K Number: K980808 · Decision May 8, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    27
    Applicant Total
    12
    Review Days
    66

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    Basic Information

    Device Name
    ENDO FMS UROLOGY
    K Number
    K980808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Future Medical Systems, Inc.
    Date Received
    March 3, 1998
    Decision Date
    May 8, 1998
    Product Code
    LJH
    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
    LJH System, Irrigation, Urological

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    K951843 REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT
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