510(k) K091257

MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM by Medi-Globe Corporation — Product Code FCG

K091257 is an FDA 510(k) premarket notification submitted by Medi-Globe Corporation for the device "MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 8, 2009. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Medi-Globe Corporation has at least 6 other 510(k) clearances on record.