ELECTRODE, FLEXIBLE SUCTION COAGULATOR

ELECTRODE, FLEXIBLE SUCTION COAGULATOR is an FDA 510(k)-cleared medical device (K130489) manufactured by Optim, LLC. 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 April 18, 2013. Regulation: 8.