SMARTRELEASE Endoscopic Soft Tissue Release System

SMARTRELEASE Endoscopic Soft Tissue Release System is an FDA 510(k)-cleared medical device (K181819) manufactured by Microaire Surgical Instruments, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 5, 2018. Regulation: 8.