MODIFICATION TO AUTO-BAND LIGATOR

MODIFICATION TO AUTO-BAND LIGATOR is an FDA 510(k)-cleared medical device (K083556) manufactured by Scandimed International. 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 February 18, 2009. Regulation: 8.