NIPRO SAFETOUCH II GAMMA

NIPRO SAFETOUCH II GAMMA is an FDA 510(k)-cleared medical device (K063721) manufactured by Nipro Medical 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 January 11, 2007. Regulation: 8.