EASY CORE DETACHABLE BIOPSY SYSTEM

EASY CORE DETACHABLE BIOPSY SYSTEM is an FDA 510(k)-cleared medical device (K051361) manufactured by Boston Scientific 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 June 15, 2005. Regulation: 8.