510(k) K112945

ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM by Inrad, Inc. — Product Code KNW

K112945 is an FDA 510(k) premarket notification submitted by Inrad, Inc. for the device "ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM". The FDA issued a decision of Substantially Equivalent on November 3, 2011. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Inrad, Inc. has at least 10 other 510(k) clearances on record.