Medical Device Manufacturer · US , Irvine , CA

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

45 submissions · 44 cleared · Since 2005

Recent clearances: Acclarent AERA Eustachian Tube Balloon Dilation System, ACCLARENT AERA Eustachian Tube Dilation System, TruDi® Navigation System V3 (FG-2000-00)

View 45 510(k) Devices ↓ Official Website

45

Total

44

Cleared

1

Denied

FDA 510(k) Regulatory Record - Acclarent, Inc. Physical Medicine ✕

3 devices

1-3 of 3

Cleared May 20, 2015

TULA Iontophoresis System with Earset

Physical Medicine · 89d

Cleared Jun 16, 2011

TULA IONTOPHORESIS SYSTEM

Physical Medicine · 104d

Cleared Mar 05, 2008

IONTOPHORESIS SYSTEM

Physical Medicine · 105d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Mar 28, 2026