510(k) K141552

ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS by Care Fusion — Product Code KNW

K141552 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS". The FDA issued a decision of Substantially Equivalent on September 5, 2014. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Care Fusion has at least 10 other 510(k) clearances on record.