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510(k) Data Aggregation

    K Number
    K013695
    Date Cleared
    2002-01-08

    (62 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To occlude and ligate vessels, ducts, tracts, and other tubular structures during Laparoscopic and general surgical procedures

    Device Description

    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.

    AI/ML Overview

    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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