APPLICATOR LOOP SUTURES

APPLICATOR LOOP SUTURES is an FDA 510(k)-cleared medical device (K911157) manufactured by Northgate Technologies, Inc.. 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 April 24, 1991. Regulation: 8.