BAUER FLEXI-TEMNO BIOPSY NEEDLE

BAUER FLEXI-TEMNO BIOPSY NEEDLE is an FDA 510(k)-cleared medical device (K902320) 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 September 30, 1990. Regulation: 8.