DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE

DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE is an FDA 510(k)-cleared medical device (K072613) manufactured by Micro Invasive Technology, 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 20, 2008. Regulation: 8.