VACUUM ASSISTED CORE BIOPSY DEVICE

VACUUM ASSISTED CORE BIOPSY DEVICE is an FDA 510(k)-cleared medical device (K042290) manufactured by Suros Surgical Systems, 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 5, 2004. Regulation: 8.