RIZA-RIBE NEEDLE

RIZA-RIBE NEEDLE is an FDA 510(k)-cleared medical device (K953441) manufactured by R-Med, 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 August 17, 1995. Regulation: 8.