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510(k) Data Aggregation
K Number
K981239Device Name
DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
Manufacturer
Date Cleared
1998-05-14
(41 days)
Product Code
Regulation Number
878.4300Why 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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