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

    Fresenius Liberty Select Cycler

    K Number: K222318 · Decision Oct 31, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    82
    Applicant Total
    51
    Review Days
    90

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    Basic Information

    Device Name
    Fresenius Liberty Select Cycler
    K Number
    K222318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care Renal Therapies Group, LLC
    Date Received
    August 2, 2022
    Decision Date
    October 31, 2022
    Product Code
    FKX
    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
    FKX System, Peritoneal, Automatic Delivery

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