MINI-UB ENDOSCOPES

MINI-UB ENDOSCOPES is an FDA 510(k)-cleared medical device (K941230) manufactured by Candela Laser Corp.. 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 June 16, 1994. Regulation: 8.