510(k) K981166

ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 by Inrad — Product Code KNW

K981166 is an FDA 510(k) premarket notification submitted by Inrad for the device "ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214". The FDA issued a decision of Substantially Equivalent on June 22, 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.