510(k) K945146

CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE by Promex, Inc. — Product Code FCG

K945146 is an FDA 510(k) premarket notification submitted by Promex, Inc. for the device "CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on December 21, 1994. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Promex, Inc. has at least 10 other 510(k) clearances on record.