KARL STORZ Trocars with Valve Seals

KARL STORZ Trocars with Valve Seals is an FDA 510(k)-cleared medical device (K254228) manufactured by Karl Storz SE & CO. KG. 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 May 10, 2026. Regulation: 8.