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510(k) Data Aggregation

    K Number
    K093409
    Device Name
    POWERPUMP ARTHROSCOPY SYSTEM
    Manufacturer
    Date Cleared
    2010-02-24

    (114 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL VISION AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PowerPump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.
    Device Description
    The PowerPump provides liquid irrigation and aspiration for arthroscopic procedures in one unit through two individual roller pumps. Both roller pumps are software controlled and automatically manage fluid and joint pressure based on procedure settings chosen by the user. If needed, both flow and pressure settings can be individually adjusted. By controlling both inflow and outflow, the PowerPump accurately regulates pressure and flow in the joint. The PowerPump also provides suction when used in conjunction with a shaver. The PowerPump consists of the following articles: 1. PowerPump Unit 2. Non-sterile Foot Control 3. Non-sterile Power Cord 4. Disposable, sterile Patient Cassette 5. Disposable, sterile Day Cassette 6. Disposable, sterile PowerPump Irrigation Tubing
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