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The Monik™ - Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.

The Disposable Endoscopic Trocar is sterile single patient use instrument consisting of a radiolucent sleeve and obturator in sizes 5mm, 10mm, 12mm long and 15mm diameter. The obturator contains a clear tapered optical element. The 10mm, 12mm diameter obturators accommodate an appropriately sided 0° endoscope and provide visibility of individual tissue layers during insertion. The trocar sleeves for the 5 mm, 10 mm, 12mm, 12mm long and 15 mm devices contain two seals. An outer integrated removable self-adjusting seal that accommodates instruments ranging from 5 mm to 15 mm in diameter where indicated and an internal seal. Together these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.

This document does not contain any information about an AI/ML device, therefore, an answer to the request cannot be generated. It describes a traditional medical device, the Monik™ - Disposable Endoscopic Trocar, and its substantial equivalence to predicate devices based on design, materials, sterilization, packaging, and performance testing.

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