Tri-Staple 2.0 Intelligent Cartridge

Tri-Staple 2.0 Intelligent Cartridge is an FDA 510(k)-cleared medical device (K163098) manufactured by Covidien, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2016. Regulation: 8.