
Covidien
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VersaOne Bladed Trocar 5mm is an FDA 510(k)-cleared medical device (K152149) 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 January 21, 2016. Regulation: 8.