REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS

REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS is an FDA 510(k)-cleared medical device (K070930) manufactured by Sterilmed, Inc.. 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 October 17, 2007. Regulation: 8.