510(k) K981721

C0-AXIAL INTRODUCER NEEDLE by Inrad — Product Code KNW

K981721 is an FDA 510(k) premarket notification submitted by Inrad for the device "C0-AXIAL INTRODUCER NEEDLE". The FDA issued a decision of Substantially Equivalent on July 28, 1998. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Inrad has at least 10 other 510(k) clearances on record.