TX BIOPSY NEEDLE

TX BIOPSY NEEDLE is an FDA 510(k)-cleared medical device (K962905) manufactured by Gallini S.R.L.. 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 October 10, 1996. Regulation: 8.