CORE NEEDLE BIOPSY

CORE NEEDLE BIOPSY is an FDA 510(k)-cleared medical device (K040266) manufactured by Remington Medical, Inc.. 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 8, 2004. Regulation: 8.