ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY

ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY is an FDA 510(k)-cleared medical device (K110913) manufactured by Endoscopic Technologies, Inc. D/B/A Estech. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 22, 2011. Regulation: 8.