OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR

OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR is an FDA 510(k)-cleared medical device (K062244) manufactured by Arthrocare Corp.. 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 October 1, 2006. Regulation: 8.