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510(k) Data Aggregation

    K Number
    K231622
    Device Name
    REGER Nebulizer Irrigation Cannula
    Date Cleared
    2023-09-29

    (119 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGER Medizintechnik, GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The REGER Nebulizer Irrigation Cannula is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site.
    Device Description
    The REGER Medizintechnik Nebulizer Irrigation Cannula is a sterile, single use stainless steel cannula with a polymer handle that is intended to nebulize irrigation fluids into the body during laparoscopic procedures. The sterile irrigation fluid is delivered from an injection pump (not provided) through the polymer tubing and into the stainless-steel shaft. The shaft has internal mechanics that deliver the fluid as microscopic droplets in a fine mist. The REGER Medizintechnik Nebulizer Irrigation Cannula is designed with a precision orifice at the tip for the deployment of a precise nebulized spray of irrigation solution into the laparoscopic cavity. The REGER Medizintechnik Nebulizer Irrigation Cannula is straight and measures between 243-245 mm from Tip to the end of the handle with a shaft diameter ranging from 3.0 - 8.0 mm. The orifice at the head of the cannula shaft ranges in diameter of 0.17mm to 0.2mm. The REGER Medizintechnik Nebulizer Irrigation Cannula also contains a 10' flexible 3.15mm outer diameter polymer tube at the handle end for attachment to attached to irrigation fluid injection pump (not provided) via a luer fitting.
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