VersaOne Bladeless Trocar

VersaOne Bladeless Trocar is an FDA 510(k)-cleared medical device (K162584) manufactured by Covidien. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 17, 2016. Regulation: 8.