UROSCOPE, ARTES MEDICAL, USA

UROSCOPE, ARTES MEDICAL, USA is an FDA 510(k)-cleared medical device (K003988) manufactured by Artes Medical USA, 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 September 5, 2001. Regulation: 8.