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

    Automatic Continuous Effusion Shunt (ACES) System ACES System

    K Number: K231096 · Decision Aug 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    122

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    Basic Information

    Device Name
    Automatic Continuous Effusion Shunt (ACES) System ACES System
    K Number
    K231096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5955
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pleural Dynamics, Inc.
    Date Received
    April 18, 2023
    Decision Date
    August 18, 2023
    Product Code
    KPM
    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
    KPM Shunt, Peritoneal

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