510(k) K081742

BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 by Baxano, Inc. — Product Code ETN

K081742 is an FDA 510(k) premarket notification submitted by Baxano, Inc. for the device "BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25". The FDA issued a decision of Substantially Equivalent on September 17, 2008. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Baxano, Inc. has at least 9 other 510(k) clearances on record.