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Gyrus Ent LLC
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GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 is an FDA 510(k)-cleared medical device (K020778) 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 May 27, 2002. Regulation: 8.