
Medtronic Advanced Energy
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Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini is an FDA 510(k)-cleared medical device (K170381) manufactured by Medtronic Advanced Energy. 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 6, 2017. Regulation: 8.