
Ethicon Endo-Surgery, LLC
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Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 is an FDA 510(k)-cleared medical device (K200841) manufactured by Ethicon Endo-Surgery, 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 10, 2020. Regulation: 8.