REVOLUTION FULL CORE BIOPSY

REVOLUTION FULL CORE BIOPSY is an FDA 510(k)-cleared medical device (K090611) manufactured by Inrad. 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 3, 2009. Regulation: 8.