UNIDRIVE SIII System

UNIDRIVE SIII System is an FDA 510(k)-cleared medical device (K223520) manufactured by Karl Storz-Endoscopy-America, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 26, 2023. Regulation: 8.