EVICEL APPLICATION DEVICE

EVICEL APPLICATION DEVICE is an FDA 510(k)-cleared medical device (K130900) manufactured by Ethicon Inc (On Behalf of Omrix Biopharaceuticals. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 12, 2013. Regulation: 8.