EvoEndo Announces US FDA 510(k) Clearance for Single-Use Unsedated Transnasal Endoscopy (TNE) System (Business Wire)

DENVER–(BUSINESS WIRE)–EvoEndo®, Inc. (“EvoEndo”), a medical device company developing systems for Unsedated Transnasal Endoscopy (TNE), has announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin marketing and sale of the EvoEndo® Single-Use Endoscopy System. The clearance follows EvoEndo’s distribution agreement with Micro-Tech Endoscopy USA, Inc. (“Micro-Tech”), which will begin a phased distribution of the EvoEndo System into hospitals and ASCs in the United States.