SELF-LIGHT DISPOSABLE ANOSCOPE

SELF-LIGHT DISPOSABLE ANOSCOPE is an FDA 510(k)-cleared medical device (K070913) manufactured by Sapimed S.P.A.. 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 August 9, 2007. Regulation: 8.