510(k) K202012

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System by Devicor Medical Products, Inc. — Product Code KNW

K202012 is an FDA 510(k) premarket notification submitted by Devicor Medical Products, Inc. for the device "Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System". The FDA issued a decision of Substantially Equivalent on August 18, 2020. 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.