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Gyrus Ent LLC
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HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM is an FDA 510(k)-cleared medical device (K033089) manufactured by Gyrus Ent LLC. 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 4, 2004. Regulation: 8.