Flexible Video-Uretero-Renoscope SSU System

Flexible Video-Uretero-Renoscope SSU System is an FDA 510(k)-cleared medical device (K212458) manufactured by Karl Storz Endoscopy America. 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 January 19, 2022. Regulation: 8.