510(k) K123259

MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM by Devicor Medical Products, Inc. — Product Code KNW

K123259 is an FDA 510(k) premarket notification submitted by Devicor Medical Products, Inc. for the device "MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM". The FDA issued a decision of Substantially Equivalent on November 15, 2012. 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.