510(k) K083802

SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 by Medi-Globe Corporation — Product Code FCG

K083802 is an FDA 510(k) premarket notification submitted by Medi-Globe Corporation for the device "SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025". The FDA issued a decision of Substantially Equivalent on March 20, 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.