Acclarent, Inc. - FDA 510(k) Cleared Devices

Acclarent, Inc. is a subsidiary of Integra LifeSciences based in Irvine, California. The company develops technology for Ear, Nose, Throat related conditions.

Acclarent has received 44 FDA 510(k) clearances from 45 total submissions since its first clearance in 2005. Ear, Nose, Throat devices represent the dominant focus, accounting for 76% of all submissions. The company's latest clearance was in 2026, demonstrating continued regulatory activity.

The company specializes in minimally invasive surgical instruments and balloon dilation systems for sinus and Eustachian tube procedures. Core product lines include navigation systems, shaver blades, curettes, and balloon catheter technologies designed for endoscopic ENT surgery.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database below.