MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT

MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT is an FDA 510(k)-cleared medical device (K010779) manufactured by Gibbons Surgical 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 April 9, 2001. Regulation: 8.