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510(k) Data Aggregation

    K Number
    K981239
    Device Name
    DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
    Manufacturer
    Date Cleared
    1998-05-14

    (41 days)

    Product Code
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEROYAL SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DeRoyal Industries Disposable Laparoscopic Clip Applier with Implantable Titanium Clips is intended for use in a variety of laparoscopic procedures to occlude tubular structures and vessels. The tissue being ligated should be consistent with the size of the clip.
    Device Description
    The DeRoyal Disposable Laparoscopic Clip Applier with Implantable Titanium Clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The Disposable Clip Applier contains up to 20 implantable titanium clips. The closed clip length is approximately 9 mm. The intended use of the device is to occlude vessels and other tubular structures during laparoscopic surgical procedures. The clip applier jaws, with the open clip in the jaws, is placed around the vessel or other tubular structure. Actuation/compression of the clip applier handle/trigger drives a mechanism within the device to close the jaws, thereby forming the clip securely around the vessel. Release/decompression of the clip applier handle/trigger allows the jaws to open and release the clip. The automatic feed feature releases the next clip into the jaws for another application. The shaft of the applier is sized to fit through a 10 mm cannula. The overall shaft length is approximately 33 mm and consistent with other endoscopic instruments.
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