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510(k) Data Aggregation

    K Number
    K141902
    Device Name
    LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER
    Date Cleared
    2015-05-26

    (316 days)

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

    LAGIS ENTERPRISES CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lagis Endoscopic Instruments Disposable Grasper has application in a variety of general, urologic, gyneoologic and endoscopic procedure for grasping and clamping of tissue and small tubular structures.
    Device Description
    The Lagis Endoscopic Instruments Disposable Grasper with 5mm diameter insulated shaft, 33cm in length, is designed for introduction and use through all appropriately sized trocar sleeves or larger sized trocar sleeves with the use of a converter. Same as predicate devices, the Lagis Endoscopic Instruments Disposable Grasper has a pair of plastic handles, which are compressed and released to close or open the instrument forceps. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. Due to different functional requirements, the instrument forceps can be of various designs such as fenestrated/atraumatic/flat/ Endo-Clinch/Babcock/CROCE-OLMI grasping forceps. The materials of construction are similar to the predicate devices and are satisfactorily tested for cytotoxicity, sensitization, intracutaneous reactivity and systematic toxicity per ISO 10993 and 21 CFR, Part 58 requirements.
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    K Number
    K090309
    Device Name
    LAGIS ENDOSCOPIC INSTRUMENTS
    Date Cleared
    2009-08-28

    (203 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAGIS ENTERPRISES CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lagis Endoscopic Instruments are designed for use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues.
    Device Description
    The Lagis Endoscopic Instruments is a sterile, single use device having an insulated shaft with a diameter of 4.5-5.0 mm for use in 6mm and larger size trocar. The shaft can be rotated through the actions of a roller knob. A pair of plastic handles manipulates closing or opening of the tip scissors or graspers. An electrical connector allows for connection of the instrument to a generator for electrosurgical applications.
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