FULL CORE BIOPSY SYSTEM

FULL CORE BIOPSY SYSTEM is an FDA 510(k)-cleared medical device (K111765) manufactured by Promex Technologies, LLC. 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 5, 2011. Regulation: 8.