Acclarent, Inc.
Medical device manufacturer in Irvine, CA.
44510(k) clearances
0PMA approvals
14recalls
Device types
- LRC Instrument, Ent Manual Surgical 13
- KAM Cannula, Sinus 8
- PGW Ear, Nose, And Throat Stereotaxic Instrument 8
- EOB Nasopharyngoscope (Flexible Or Rigid) 4
- EGJ Device, Iontophoresis, Other Uses 3
- PNZ Eustachian Tube Balloon Dilation Device 3
- ETD Tube, Tympanostomy 2
- KTI Bronchoscope Accessory 2
- QGK Balloon, Nasal Airway 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation SystemPNZ · Traditional | 02/19/2026SE |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation SystemPNZ · Traditional | 12/13/2023SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | 07/21/2023SE |
| K221037 | TruDi Shaver BladePGW · Traditional | 07/20/2022SE |
| K201115 | Next Generation Balloon Dilation SystemLRC · Traditional | 08/27/2020SE |
| K201174 | TruDi CurettePGW · Traditional | 08/12/2020SE |
| K193453 | TruDi ProbePGW · Traditional | 03/23/2020SE |
| K190532 | TruDi NAV WirePGW · Traditional | 05/03/2019SE |
| K190525 | RELIEVA ULTIRRA Sinus Balloon CatheterLRC · Traditional | 05/03/2019SE |
| K183090 | Relieva Tract Balloon Dilation SystemQGK · Traditional | 04/19/2019SE |
| K180948 | TruDi NAV Suction InstrumentsPGW · Traditional | 07/20/2018SE |
| K173628 | Acclarent ENT Navigation SystemPGW · Special | 03/10/2018SE |
| K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation SystemPNZ · Traditional | 01/16/2018SE |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty SystemLRC · Traditional | 09/05/2017SE |
| K161698 | Relieva UltirraNav Sinus Balloon CatheterLRC · Traditional | 10/24/2016SE |
| K161697 | Acclarent NavWire Sinus Navigation GuidewirePGW · Traditional | 10/24/2016SE |
| K153341 | Relieva Scout Multi-Sinus Dilation SystemLRC · Traditional | 02/12/2016SE |
| K150453 | TULA Iontophoresis System with EarsetEGJ · Special | 05/20/2015SE |
| K143541 | Relieva SpinPlus Balloon Sinuplasty SystemLRC · Traditional | 04/22/2015SE |
| K150172 | ACCLARENT SE Inflation DeviceLRC · Special | 04/07/2015SE |
| K132433 | Acclarent Cyclops Multi-Angle EndoscopeEOB · Traditional | 04/24/2014SE |
| K140160 | Relieva Scout Sinus Dilation SystemLRC · Special | 02/20/2014SE |
| K120280 | Relieva Seeker Balloon Sinuplasty SystemLRC · Traditional | 11/05/2012SE |
| K111875 | Relieva Spin Sinus Dilation SystemLRC · Traditional | 10/11/2011SE |
| K110687 | Relieva Stratus Pro Microflow Spacer (Frontal)KAM · Special | 10/07/2011SE |
| K111254 | Relieva Solo Elite Sinus Balloon CatheterLRC · Traditional | 08/22/2011SE |
| K110636 | Tula Iontophoresis SystemEGJ · Traditional | 06/16/2011SE |
| K110097 | Acclarent Cyclops Multi-Angle EndoscopeEOB · Special | 05/27/2011SE |
| K103595 | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemETD · Traditional | 04/01/2011SE |
| K110218 | Inspira Air Balloon Dilation SystemKTI · Special | 03/31/2011SE |
| K100577 | Acclarent Cyclops Multi-Angle EndoscopeEOB · Traditional | 01/06/2011SE |
| K093594 | Modification to Relieva Stratus Microflow SpacerKAM · Special | 03/03/2010SE |
| K090660 | Airway Balloon Catheter Inflation DeviceKTI · Traditional | 06/12/2009SE |
| K083574 | Relieva Stratus Microflow SpacerKAM · Traditional | 01/29/2009SE |
| K082188 | Tympanostomy TubeETD · Traditional | 09/19/2008SE |
| K072891 | Sinus SpacerKAM · Traditional | 03/19/2008SE |
| K073041 | Relieva and Relieva Acella Sinus Balloon CatheterKAM · Traditional | 03/11/2008SE |
| K073276 | Iontophoresis SystemEGJ · Traditional | 03/05/2008SE |
| K071845 | Relieva Luma Sinus Illumination System, Model SIS-100AKAM · Traditional | 09/28/2007SE |
| K063078 | MicroendoscopeEOB · Traditional | 10/24/2006SE |
| K062458 | Ethmoid Sinus SpacerKAM · Traditional | 09/15/2006SE |
| K061903 | Relieva Sinus Balloon CatheterLRC · Special | 08/18/2006SE |
| K060974 | Relient Navigation DeviceKAM · Special | 05/05/2006SE |
| K052198 | Relieva Sinus Balloon Inflation DeviceLRC · Traditional | 08/31/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0127-2024 Class II | TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi…When using affected curette and software, there is a discrepancy between the actual curette tip location and… | 09/21/2023Open, Classified |
| Z-0415-2022 Class II | TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and…Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for… | 11/12/2021Open, Classified |
| Z-0826-2020 Class II | TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing… | 03/06/2019Terminated |
| Z-0825-2020 Class II | TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing… | 03/06/2019Terminated |
| Z-0824-2020 Class II | TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing… | 03/06/2019Terminated |
| Z-1740-2015 Class III | RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus…Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. | 04/28/2015Terminated |
| Z-1866-2013 Class II | Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1865-2013 Class II | Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1864-2013 Class II | Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1863-2013 Class II | Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1862-2013 Class II | Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1861-2013 Class II | Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1860-2013 Class II | Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1095-2012 | Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc.…Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially… | 01/30/2012Terminated |