
Olympus Surgical Technologies America
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POWERSEAL Curved Jaw Sealer and Divider, Double Action is an FDA 510(k)-cleared medical device (K212643) manufactured by Olympus Surgical Technologies America. 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 September 26, 2021. Regulation: 8.