510(k) K161805

EnCor MRI Introducer Set, EnCor Probe Introducer by Senorx, Inc. — Product Code KNW

K161805 is an FDA 510(k) premarket notification submitted by Senorx, Inc. for the device "EnCor MRI Introducer Set, EnCor Probe Introducer". The FDA issued a decision of Substantially Equivalent on July 19, 2016. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Senorx, Inc. has at least 10 other 510(k) clearances on record.