SURECORE BIOPSY DEVICE

SURECORE BIOPSY DEVICE is an FDA 510(k)-cleared medical device (K102756) manufactured by Chest Innovations, 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 November 28, 2011. Regulation: 8.