
Covidien (Part of Medtronic)
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Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads is an FDA 510(k)-cleared medical device (K253657) manufactured by Covidien (Part of Medtronic). 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 April 9, 2026. Regulation: 8.