SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM

SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM is an FDA 510(k)-cleared medical device (K032506) manufactured by Sanarus 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 October 8, 2003. Regulation: 8.