
Directed Energy, Inc.
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MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. is an FDA 510(k)-cleared medical device (K880216) manufactured by Directed Energy, Inc.. 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 March 3, 1988. Regulation: 8.