ADVANCED UROSCIENCE INJECTION NEEDLE

ADVANCED UROSCIENCE INJECTION NEEDLE is an FDA 510(k)-cleared medical device (K002323) manufactured by Advanced Uroscience, 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 July 30, 2000. Regulation: 8.