510(k) K080494

BAXANO ULTRA LOW PROFILE RONGEUR by Baxano, Inc. — Product Code HAE

K080494 is an FDA 510(k) premarket notification submitted by Baxano, Inc. for the device "BAXANO ULTRA LOW PROFILE RONGEUR". The FDA issued a decision of Substantially Equivalent on March 4, 2008. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Baxano, Inc. has at least 9 other 510(k) clearances on record.