The EvoEndo^® Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb in patients over the age of five. 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^® Endoscope for endoscopic diagnosis, treatment, and video observation.