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

    LIGHTHOUSE(TM) URINARY CATHETER

    K Number: K131655 · Decision Nov 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    2
    Review Days
    151

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    Basic Information

    Device Name
    LIGHTHOUSE(TM) URINARY CATHETER
    K Number
    K131655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seedings Life Science Ventures, LLC
    Date Received
    June 6, 2013
    Decision Date
    November 4, 2013
    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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    Other Clearances by Seedings Life Science Ventures, LLC

    K Number Device Name
    K140099 LIGHTHOUSE URINARY CATHETER