VACUUM ASSISTED CORE BIOPSY DEVICE

VACUUM ASSISTED CORE BIOPSY DEVICE is an FDA 510(k)-cleared medical device (K010400) manufactured by Promex, 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 July 23, 2001. Regulation: 8.