Reprocessed Endoscopic Trocars and Sleeves

Reprocessed Endoscopic Trocars and Sleeves is an FDA 510(k)-cleared medical device (K201511) 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 July 30, 2020. Regulation: 8.