510(k) K132848

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

K132848 is an FDA 510(k) premarket notification submitted by Mectron S.P.A. for the device "PIEZOSURGERY FLEX". The FDA issued a decision of Substantially Equivalent on November 29, 2013. 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.