510(k) K150728

XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole by Medtronic Xomed, Inc. — Product Code ERL

K150728 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole". The FDA issued a decision of Substantially Equivalent on August 14, 2015. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. Medtronic Xomed, Inc. has at least 10 other 510(k) clearances on record.