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510(k) Data Aggregation

    K Number
    K243867
    Device Name
    LAGIS Suction Irrigation System
    Manufacturer
    Lagis Enterprise Co., Ltd.
    Date Cleared
    2025-03-17

    (90 days)

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

    Lagis Enterprise Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAGIS Suction Irrigation System has applications in laparoscopic procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
    Device Description
    The LAGIS Suction Irrigation System consists of flexible tubing attached to a plastic housing/handle with a spring activated valve/stopper. Attached distally is a stainless steel probe and proximally is a plastic housing cap. When properly connected and operated, the device irrigates and evacuates fluids during laparoscopic procedures. The LAGIS Suction Irrigation System has multiple models, which can be categorized into two types based on the handle design, including direct type (e.g., SA-360C) and trumpet type (e.g., SA-320CT). Despite the different handle designs, all models provide the same function.
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    K Number
    K240334
    Device Name
    LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)
    Manufacturer
    Lagis Enterprise Co., Ltd.
    Date Cleared
    2024-10-30

    (268 days)

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

    Lagis Enterprise Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAGIS Endoscopic Instruments-Grasper has applications in a variety of minimally invasive procedures to facilitate grasping and mobilization of tissue.
    Device Description
    The LAGIS Endoscopic Instruments - Grasper is a single use device sterilized by ethylene oxide. It is composed of an insulating shaft, a rotation knob, grasping forceps, and a ratchet handle. The 5 mm diameter insulating shaft is designed for use through appropriate size trocars. The rotation knob located on the handle rotates the insulating shaft 360 degrees in either direction for better maneuverability. With the ratchet handle, the grasping forceps are allowed to be locked in place. The grasping forceps are activated by compression and release of the ring of the handle.
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