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510(k) Data Aggregation

    K Number
    K093479
    Device Name
    DISPOSABLE SUCTION AND IRRIGATION SYSTEM
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2010-05-19

    (191 days)

    Product Code
    FHF
    Regulation Number
    876.4370
    Why did this record match?
    Product Code :

    FHF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Suction And Irrigation System is used to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to remove fluid waste, tissue debris and smoke from the surgical site.
    Device Description
    The Disposable Suction And Irrigation System is composed of a stainless steel Suction / Irrigation Probe which is connected to a handle having two trumpet type valves. Using the fingers, the action of depressing one valve will control the irrigation fluid from the Poly Venyl Chloride (PVC) tubing through the irrigation probe and be delivered onto the site of surgery. By depressing the other valve would enable the action of suction to remove blood and tissue debris from the site of surgery through the suction probe and these will be transported through the PVC tubing and be deposited into a waste container. The handle is joined to two PVC tubes. One divides itself into two branches to conduct irrigation fluids from a saline bag. The clamp is used to hold the two tubes in a vertical position. This irrigation fluid passes down the tubes, then through the Suction / Irrigation Probe and is deposited onto the surgical site. The other tube will conduct waste tissue debris or blood or smoke. A vacuum pump will be connected to the Suction end to draw the tissue debris or blood or smoke from the site of surgery, through the stainless steel Suction / Irrigation Probe and these are transported through this PVC tubing until they are deposited into a waste container. This device is for single use only.
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    K Number
    K003443
    Device Name
    SUCTION IRRIGATOR
    Manufacturer
    APPLIED MEDICAL
    Date Cleared
    2001-02-01

    (87 days)

    Product Code
    FHF
    Regulation Number
    876.4370
    Why did this record match?
    Product Code :

    FHF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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