Acclarent, Inc.
FDA 510(k) & PMA Approved Devices — 18 products
Total Devices18
Categories4
Latest Approval2026-02-19
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | PNZ | 2026-02-19 | View |
| 510(k) | K230742 | ACCLARENT AERA Eustachian Tube Dilation System | PNZ | 2023-12-13 | View |
| 510(k) | K231862 | TruDi® Navigation System V3 (FG-2000-00) | PGW | 2023-07-21 | View |
| 510(k) | K221037 | TruDi Shaver Blade | PGW | 2022-07-20 | View |
| 510(k) | K201115 | Next Generation Balloon Dilation System | LRC | 2020-08-27 | View |
| 510(k) | K201174 | TruDi Curette | PGW | 2020-08-12 | View |
| 510(k) | K193453 | TruDi Probe | PGW | 2020-03-23 | View |
| 510(k) | K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | LRC | 2019-05-03 | View |
| 510(k) | K190532 | TruDi NAV Wire | PGW | 2019-05-03 | View |
| 510(k) | K183090 | Relieva Tract Balloon Dilation System | QGK | 2019-04-19 | View |
| 510(k) | K180948 | TruDi NAV Suction Instruments | PGW | 2018-07-20 | View |
| 510(k) | K173628 | Acclarent ENT Navigation System | PGW | 2018-03-10 | View |
| 510(k) | K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System | PNZ | 2018-01-16 | View |
| 510(k) | K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | LRC | 2017-09-05 | View |
| 510(k) | K161697 | Acclarent NavWire Sinus Navigation Guidewire | PGW | 2016-10-24 | View |
| 510(k) | K161698 | Relieva UltirraNav Sinus Balloon Catheter | LRC | 2016-10-24 | View |
| 510(k) | DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation System | PNZ | 2016-09-16 | View |
| 510(k) | K153341 | Relieva Scout Multi-Sinus Dilation System | LRC | 2016-02-12 | View |
No matching devices.