PRO-B BIOPSY NEEDLE

PRO-B BIOPSY NEEDLE is an FDA 510(k)-cleared medical device (K951598) manufactured by Promedical , 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 April 20, 1995. Regulation: 8.