MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM

MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM is an FDA 510(k)-cleared medical device (K091257) 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 May 7, 2009. Regulation: 8.