REPROCESSED ENDOSCOPIC TROCARS

REPROCESSED ENDOSCOPIC TROCARS is an FDA 510(k)-cleared medical device (K121240) manufactured by Sterilmed, Inc.. 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 June 10, 2012. Regulation: 8.