
Medtronic Advanced Energy, LLC
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AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR is an FDA 510(k)-cleared medical device (K132974) manufactured by Medtronic Advanced Energy, 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 December 2, 2013. Regulation: 8.