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EvoEndo Awarded FDA’s 510(k) Clearance for Its Transnasal Endoscopy System

February 22, 2022

EvoEndo has received the FDA’s 510(k) clearance for its EvoEndo single-use endoscopy system.

The system features flexible endoscopes, a portable video controller and a “comfort kit” containing virtual reality goggles for patient entertainment during the procedure to allow for unsedated transnasal endoscopy, the company said.

EvoEndo has a distribution agreement with Micro-Tech Endoscopy USA, which will begin phased distribution of the system to U.S. hospitals and surgery centers.

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