510(k) K201115

Next Generation Balloon Dilation System by Acclarent, Inc. — Product Code LRC

K201115 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "Next Generation Balloon Dilation System". The FDA issued a decision of Substantially Equivalent on August 27, 2020. 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.