510(k) K112506

XPRESS MULTI-SINUS DILATION TOOL by Entellus Medical, Inc. — Product Code LRC

K112506 is an FDA 510(k) premarket notification submitted by Entellus Medical, Inc. for the device "XPRESS MULTI-SINUS DILATION TOOL". The FDA issued a decision of Substantially Equivalent on December 21, 2011. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. Entellus Medical, Inc. has at least 10 other 510(k) clearances on record.