
Gyrus Acmi, Inc.
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POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) is an FDA 510(k)-cleared medical device (K252487) manufactured by Gyrus Acmi, Inc.. 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 March 1, 2026. Regulation: 8.