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

    IRRAflow Active Fluid Exchange System (AFES)

    K Number: K231664 · Decision Oct 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    2
    Review Days
    134

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    Basic Information

    Device Name
    IRRAflow Active Fluid Exchange System (AFES)
    K Number
    K231664
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Irras USA, Inc.
    Date Received
    June 7, 2023
    Decision Date
    October 19, 2023
    Product Code
    JXG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JXG Shunt, Central Nervous System And Components

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    Other Clearances by Irras USA, Inc.

    K Number Device Name
    K200807 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit