ENCOR ENSPIRE BREAST BIOPSY SYSTEM

ENCOR ENSPIRE BREAST BIOPSY SYSTEM is an FDA 510(k)-cleared medical device (K111100) manufactured by C.R. Bard, 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 June 15, 2011. Regulation: 8.