EASY CORE BIOPSY SYSTEM

EASY CORE BIOPSY SYSTEM is an FDA 510(k)-cleared medical device (K040893) 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 May 5, 2004. Regulation: 8.