510(k) K093256

SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 by Inrad — Product Code KNW

K093256 is an FDA 510(k) premarket notification submitted by Inrad for the device "SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018". The FDA issued a decision of Substantially Equivalent on November 17, 2009. 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.