EndoArmor™ + Surgical Gown

EndoArmor™ + Surgical Gown is an FDA 510(k)-cleared medical device (K203548) manufactured by Boston Scientific Corporation. 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 February 20, 2022. Regulation: 8.