VACUFLASH BIOPSY SYSTEM

VACUFLASH BIOPSY SYSTEM is an FDA 510(k)-cleared medical device (K024089) manufactured by Bip USA, 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 March 10, 2003. Regulation: 8.