510(k) K051247

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

K051247 is an FDA 510(k) premarket notification submitted by Medi-Globe Corp. for the device "SONOTIP II ULTRASOUND NEEDLE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 16, 2005. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Medi-Globe Corp. has at least 10 other 510(k) clearances on record.