AUTOMATED TRU-CUT BIOPSY DEVICE

AUTOMATED TRU-CUT BIOPSY DEVICE is an FDA 510(k)-cleared medical device (K954529) manufactured by Baxter Healthcare Corp. 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 December 28, 1995. Regulation: 8.