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