510(k) K153709

Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet by Devicor Medical Products, Inc. — Product Code KNW

K153709 is an FDA 510(k) premarket notification submitted by Devicor Medical Products, Inc. for the device "Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet". The FDA issued a decision of Substantially Equivalent on August 8, 2016. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Devicor Medical Products, Inc. has at least 10 other 510(k) clearances on record.