AUTOMATED CORE BIOPSY DEVICE

AUTOMATED CORE BIOPSY DEVICE is an FDA 510(k)-cleared medical device (K011270) 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 June 21, 2001. Regulation: 8.