TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM

TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM is an FDA 510(k)-cleared medical device (K002583) manufactured by Vidamed, 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 February 12, 2001. Regulation: 8.