VANGUARD REPROCESSED SUTURE PASSER

VANGUARD REPROCESSED SUTURE PASSER is an FDA 510(k)-cleared medical device (K053585) manufactured by Ascent Healthcare Solutions. 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 10, 2006. Regulation: 8.