SONOTIP II ULTRASOUND NEEDLE SYSTEM

SONOTIP II ULTRASOUND NEEDLE SYSTEM is an FDA 510(k)-cleared medical device (K070129) manufactured by Medi-Globe Corporation. 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 30, 2007. Regulation: 8.