510(k) K954265

TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE by Promex, Inc. — Product Code KNW

K954265 is an FDA 510(k) premarket notification submitted by Promex, Inc. for the device "TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE". The FDA issued a decision of Substantially Equivalent on September 29, 1995. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Promex, Inc. has at least 10 other 510(k) clearances on record.