
Medi-Globe Corporation
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SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM is an FDA 510(k)-cleared medical device (K133763) 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 14, 2014. Regulation: 8.