REPROCESSED DILATING TIP TROCARS

REPROCESSED DILATING TIP TROCARS is an FDA 510(k)-cleared medical device (K132629) manufactured by Stryker Sustainability Solutions. 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 December 30, 2013. Regulation: 8.