510(k) K153743

PIEZOSURGERY PLUS by Mectron S.P.A. — Product Code JDX

K153743 is an FDA 510(k) premarket notification submitted by Mectron S.P.A. for the device "PIEZOSURGERY PLUS". The FDA issued a decision of Substantially Equivalent on May 25, 2016. The device falls under product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment), a Class II device regulated under 21 CFR 888.4580. Mectron S.P.A. has at least 10 other 510(k) clearances on record.