510(k) K113522

PATHASSIST LIGHT SEEKER by Entellus Medical, Inc. — Product Code LRC

K113522 is an FDA 510(k) premarket notification submitted by Entellus Medical, Inc. for the device "PATHASSIST LIGHT SEEKER". The FDA issued a decision of Substantially Equivalent on January 27, 2012. 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.