
Smith & Nephew
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LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application is an FDA 510(k)-cleared medical device (K153606) manufactured by Smith & Nephew. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 1, 2016. Regulation: 8.