DIRECTVISION GUIDE SYSTEM

DIRECTVISION GUIDE SYSTEM is an FDA 510(k)-cleared medical device (K091600) manufactured by Percuvision, LLC. 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 August 24, 2009. Regulation: 8.