ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP

ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP is an FDA 510(k)-cleared medical device (K130059) manufactured by Ibi Israel Biomedical Innovations , Ltd.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 2013. Regulation: 8.