KSEA SCB-RUI SCO

KSEA SCB-RUI SCO is an FDA 510(k)-cleared medical device (K003113) manufactured by KARL STORZ Endoscopy-America, Inc.. 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 March 26, 2001. Regulation: 8.