Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) is an FDA 510(k)-cleared medical device (K221629) manufactured by Covidien. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 21, 2023. Regulation: 8.