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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. The gastroscope is a sterile single-use device and can be inserted orally or transnasally. The 110 cm gastroscope is intended to be used in adult and pediatric populations. The 85 cm gastroscope is intended to be used in the pediatric population.

The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation.

The EvoEndo Endoscopy System is comprised of three regulated components:

• EvoEndo Model LE Single-Use Gastroscope (hereafter referred to as the EvoEndo Endoscope)
• EvoEndo Reusable Video Cable (hereafter referred to as the Video Cable)
• 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:

• 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.

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