PROACT BIOPSY NEEDLE ENCHANCEMENTS

PROACT BIOPSY NEEDLE ENCHANCEMENTS is an FDA 510(k)-cleared medical device (K926559) manufactured by Proact, Ltd.. 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 21, 1993. Regulation: 8.