TRU-CORE NEEDLE SET

TRU-CORE NEEDLE SET is an FDA 510(k)-cleared medical device (K943368) manufactured by Ideamatrix. 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 July 28, 1994. Regulation: 8.