510(k) K150172

ACCLARENT SE Inflation Device by Acclarent, Inc. — Product Code LRC

K150172 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "ACCLARENT SE Inflation Device". The FDA issued a decision of Substantially Equivalent on April 7, 2015. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. Acclarent, Inc. has at least 10 other 510(k) clearances on record.