MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM

MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM is an FDA 510(k)-cleared medical device (K903620) manufactured by Smith & Nephew Dyonics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 11, 1990. Regulation: 8.