BIOMARC COAXIAL NEEDLE

BIOMARC COAXIAL NEEDLE is an FDA 510(k)-cleared medical device (K133148) manufactured by Carbon Medical Technologies, 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 May 12, 2014. Regulation: 8.