510(k) K110739

ENTELLUS MEDICAL SINUS GUIDEWIRE by Entellus Medical, Inc. — Product Code LRC

K110739 is an FDA 510(k) premarket notification submitted by Entellus Medical, Inc. for the device "ENTELLUS MEDICAL SINUS GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on June 14, 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.