510(k) K070129

SONOTIP II ULTRASOUND NEEDLE SYSTEM by Medi-Globe Corporation — Product Code FCG

K070129 is an FDA 510(k) premarket notification submitted by Medi-Globe Corporation for the device "SONOTIP II ULTRASOUND NEEDLE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 31, 2007. 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.