COOK SIDEARM CORE TISSUE BIOPSY DEVICE

COOK SIDEARM CORE TISSUE BIOPSY DEVICE is an FDA 510(k)-cleared medical device (K041544) manufactured by Urological, 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 21, 2004. Regulation: 8.