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

    CURE CATHETER CLOSED SYSTEM

    K Number: K080881 · Decision Jun 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    4
    Review Days
    72

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    Basic Information

    Device Name
    CURE CATHETER CLOSED SYSTEM
    K Number
    K080881
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cure Medical, LLC
    Date Received
    March 31, 2008
    Decision Date
    June 11, 2008
    Product Code
    KOD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOD Catheter, Urological

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    Other Clearances by Cure Medical, LLC

    K Number Device Name
    K132500 CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
    K110653 CURE CATHETER
    K072539 CURE CATHETER