
Power Medical Interventions, Inc.
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SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL is an FDA 510(k)-cleared medical device (K020343) manufactured by Power Medical Interventions, 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 April 9, 2002. Regulation: 8.