INJEKT FILIFORM INJECTION NEEDLE

INJEKT FILIFORM INJECTION NEEDLE is an FDA 510(k)-cleared medical device (K082319) manufactured by Cook Urological, 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 24, 2008. Regulation: 8.