URETHRAL DILATOR ENDOSCOPE

URETHRAL DILATOR ENDOSCOPE is an FDA 510(k)-cleared medical device (K874530) manufactured by Advanced Surgical Intervention, 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 January 26, 1988. Regulation: 8.