CASSI II Rotational Core Biopsy System

CASSI II Rotational Core Biopsy System is an FDA 510(k)-cleared medical device (K161234) manufactured by Scion Medical Technologies, LLC. 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 August 2, 2016. Regulation: 8.