510(k) K140137

SAFETY BIOPSY NEEDLE SYSTEM by Pfm Medical, Inc. — Product Code FCG

K140137 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "SAFETY BIOPSY NEEDLE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 25, 2014. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Pfm Medical, Inc. has at least 10 other 510(k) clearances on record.