510(k) K143541

Relieva SpinPlus Balloon Sinuplasty System by Acclarent, Inc. — Product Code LRC

K143541 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "Relieva SpinPlus Balloon Sinuplasty System". The FDA issued a decision of Substantially Equivalent on April 22, 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.