18 GAUGE TRU-CUT BIOPSY NEEDLE

18 GAUGE TRU-CUT BIOPSY NEEDLE is an FDA 510(k)-cleared medical device (K960509) manufactured by Baxter Healthcare Corp. 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 3, 1996. Regulation: 8.