MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY

MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY is an FDA 510(k)-cleared medical device (K022879) 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 September 22, 2002. Regulation: 8.