K-C HEMOSTATIC BIOPSY SYSTEM

K-C HEMOSTATIC BIOPSY SYSTEM is an FDA 510(k)-cleared medical device (K050135) manufactured by Bioengineering Consultants , Ltd.. 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 July 12, 2005. Regulation: 8.