VIVAMED FISTULA NEEDLE

VIVAMED FISTULA NEEDLE is an FDA 510(k)-cleared medical device (K903440) manufactured by S.S. Ent.. 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 April 19, 1992. Regulation: 8.