EvoEndo’s Single-Use Endoscopy System allows patients five and older to undergo a transnasal or transoral EGD exam. EvoEndo’s sterile, portable, ultra-slim 3.5 mm gastroscope with 2 mm working channel, virtual reality patient distraction, and training program are specifically designed to help physicians and hospitals offer an unsedated upper gastrointestinal (GI) endoscopy alternative without anesthesia or sedation to their patients and their families.
FDA Cleared Indications for Use
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.