510(k) K944944

CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE by Promedical , Ltd. — Product Code FCG

K944944 is an FDA 510(k) premarket notification submitted by Promedical , Ltd. 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. Promedical , Ltd. has at least 4 other 510(k) clearances on record.