BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    LoFric Elle Pro

    K Number: K260999 · Decision Apr 24, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    2
    Review Days
    29

    Basic Information

    Device Name
    LoFric Elle Pro
    K Number
    K260999
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wellspect AB
    Date Received
    March 26, 2026
    Decision Date
    April 24, 2026
    Product Code
    EZD
    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
    EZD Catheter, Straight

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    Other Clearances by Wellspect AB

    K Number Device Name
    K250659 LoFric Origo