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510(k) Data Aggregation
(62 days)
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10
To occlude and ligate vessels, ducts, tracts, and other tubular structures during Laparoscopic and general surgical procedures
The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips is a reusable instrument designed for use with a disposable clip cartridge that is advanced inside the clip applier shaft. The rotatable clip applier shaft is sized to fit through a 10mm trocar. The Microline Reusable Laparoscopic Clip Applier is sold with a pre-loaded clip cartridge which contains 19 rectangular implantable titanium single-use surgical clips (width 5.4mm) that can be applied one at a time after firing. Cartidge loading is performed through a slot located in the rear of the instrument, in line with the instrument's shaft. Cartridge loading and unloading can be performed in-vivo without removing the Clip Applier from the trocar.
The provided text is a 510(k) summary for the Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Clips. This document asserts substantial equivalence to predicate devices and does not describe a clinical study with acceptance criteria, device performance, or ground truth.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on similarity to already approved devices rather than new performance data.
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