GENERAL SURGICAL LAPAROSCOPES

GENERAL SURGICAL LAPAROSCOPES is an FDA 510(k)-cleared medical device (K003803) manufactured by Global Endoscopy, 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 March 6, 2001. Regulation: 8.