Signia Stapler (with new software)

Signia Stapler (with new software) is an FDA 510(k)-cleared medical device (K201672) manufactured by Covidien. 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 July 16, 2020. Regulation: 8.