SAPH-LOOP LIGATING LOOP

SAPH-LOOP LIGATING LOOP is an FDA 510(k)-cleared medical device (K022410) manufactured by Genzyme Biosurgery. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 19, 2002. Regulation: 8.