SANARUS CORE TISSUE BIOPSY SYSTEM

SANARUS CORE TISSUE BIOPSY SYSTEM is an FDA 510(k)-cleared medical device (K003528) manufactured by Endocare, 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 2, 2001. Regulation: 8.