510(k) K935844

GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA by Medi-Globe Corp. — Product Code FCG

K935844 is an FDA 510(k) premarket notification submitted by Medi-Globe Corp. for the device "GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA". The FDA issued a decision of Substantially Equivalent on February 13, 1995. 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.