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Polypectomy is a procedure whereby a polyp is removed from the gastrointestinal tract. A polypectomy snare is an instrument which enables the physician to grasp the polyp, transmit electrical current and transect the polyp.

The polypectomy snare is introduced through an endoscope and the snare wire is place around the polyp. The snare wire is closed while simultaneously transmitting electrocautery to excise the polyp. Polypectomy snares have been clinically used for more than years. Some Endoscope models have irrigation and suction 20 capabilities that are commonly used during polypectomy procedures. irrigation/aspiration polypectomy snare incorporates these The capabilities into one device.

This document does not contain the specific information requested regarding acceptance criteria and a study proving device performance in the format of a clinical trial or performance study. The provided text is a 510(k) summary for a polypectomy snare, focusing on its intended use, contraindications, and manufacturing overview. It references general clinical use of polypectomy snares and manufacturing standards but does not detail a study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement for assessing the performance of this particular device.

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