ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM

ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM is an FDA 510(k)-cleared medical device (K933470) manufactured by Kinetix Instruments. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 24, 1994. Regulation: 8.