INJECTION NEEDLE PROBE/DEVICE-TUNIS

INJECTION NEEDLE PROBE/DEVICE-TUNIS is an FDA 510(k)-cleared medical device (K983765) manufactured by Ximed/Prosure/Injectx. 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 December 10, 1998. Regulation: 8.