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The EvoEndo Model LE Gastroscope is intended for the upper digestive tract in adults and pediativ patients, specifically for the observation, diagnosis treatment of the esophagus, stomach, and duodenal bulb in patients over the age of five years. The gastroscope is a sterile single-use device and can be inserted orally or transnasally. The EvoEndo Controller is intended for use with an EvoEndo Endoscopic diagnosis, treament, and video observation.

The EvoEndo Endoscopy System is comprised of two regulated components: - EvoEndo Model LE Single-Use Gastroscope (hereafter referred to as the EvoEndo Endoscope) - EvoEndo Controller (hereafter referred to as the Controller) ● The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of: - o Handle - Umbilical Bundle that includes air, water, and suction lines, as well as the video connector ● - Endoscope shaft with HD Camera ● The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable.