GENYX FLEXIBLE INJECTION NEEEDLE

GENYX FLEXIBLE INJECTION NEEEDLE is an FDA 510(k)-cleared medical device (K001146) manufactured by Geny Medical, 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 June 29, 2000. Regulation: 8.