FDA 510(k) Applications Submitted by ACCLARENT, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K161697 |
06/20/2016 |
Acclarent NavWire Sinus Navigation Guidewire |
ACCLARENT, INC. |
| K093594 |
11/19/2009 |
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER |
ACCLARENT, INC. |
| K120280 |
01/30/2012 |
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM |
ACCLARENT, INC. |
| K110687 |
03/11/2011 |
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) |
ACCLARENT, INC. |
| K062458 |
08/23/2006 |
ETHMOID SINUS SPACER |
ACCLARENT, INC. |
| K063078 |
10/10/2006 |
MICROENDOSCOPE |
ACCLARENT, INC. |
| K110636 |
03/04/2011 |
TULA IONTOPHORESIS SYSTEM |
ACCLARENT, INC. |
| K103595 |
12/08/2010 |
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM |
ACCLARENT, INC. |
| K132433 |
08/05/2013 |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
ACCLARENT, INC. |
| K140160 |
01/22/2014 |
RELIEVA SCOUT SINUS DILATION SYSTEM |
ACCLARENT, INC. |
| K161698 |
06/20/2016 |
Relieva UltirraNav Sinus Balloon Catheter |
ACCLARENT, INC. |
| K153341 |
11/19/2015 |
Relieva Scout Multi-Sinus Dilation System |
ACCLARENT, INC. |
| DEN150056 |
12/07/2015 |
Acclarent Aera Eustachian Tube Balloon Dilation System |
ACCLARENT, INC. |
| K150172 |
01/26/2015 |
ACCLARENT SE Inflation Device |
ACCLARENT, INC. |
| K171687 |
06/07/2017 |
Relieva SpinPlus Nav Balloon Sinuplasty System |
Acclarent, Inc. |
| K171761 |
06/14/2017 |
ACCLARENT AERA Eustachian Tube Balloon Dilation System |
Acclarent, Inc. |
| K230742 |
03/17/2023 |
ACCLARENT AERA Eustachian Tube Dilation System |
Acclarent, Inc. |
| K231862 |
06/23/2023 |
TruDi« Navigation System V3 (FG-2000-00) |
Acclarent, Inc. |
| K110097 |
01/13/2011 |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
ACCLARENT, INC. |
| K110218 |
01/25/2011 |
INSPIRA AIR BALLOON DILATION SYSTEM |
ACCLARENT, INC. |
| K100577 |
03/01/2010 |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
ACCLARENT, INC. |
| K090660 |
03/12/2009 |
AIRWAY BALLOON CATHETER INFLATION DEVICE |
ACCLARENT, INC. |
| K111875 |
07/01/2011 |
RELIEVA SPIN SINUS DILATION SYSTEM |
ACCLARENT, INC. |
| K061903 |
07/05/2006 |
RELIEVA SINUS BALLOON CATHETER |
ACCLARENT, INC. |
| K071845 |
07/05/2007 |
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A |
ACCLARENT, INC. |
| K082188 |
08/04/2008 |
TYMPANOSTOMY TUBE |
ACCLARENT, INC. |
| K072891 |
10/10/2007 |
SINUS SPACER |
ACCLARENT, INC. |
| K073041 |
10/29/2007 |
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER |
ACCLARENT, INC. |
| K073276 |
11/21/2007 |
IONTOPHORESIS SYSTEM |
ACCLARENT, INC. |
| K083574 |
12/03/2008 |
RELIEVA STRATUS MICROFLOW SPACER |
ACCLARENT, INC. |
| K111254 |
05/04/2011 |
RELIEVA SOLO ELITE SINUS BALLOON CATHETER |
ACCLARENT, INC. |
| K190525 |
03/04/2019 |
RELIEVA ULTIRRA Sinus Balloon Catheter |
Acclarent, Inc. |
| K190532 |
03/04/2019 |
TruDi NAV Wire |
Acclarent, Inc. |
| K180948 |
04/11/2018 |
TruDi NAV Suction Instruments |
Acclarent, Inc. |
| K201174 |
05/01/2020 |
TruDi Curette |
Acclarent, Inc. |
| K183090 |
11/06/2018 |
Relieva Tract Balloon Dilation System |
Acclarent, Inc. |
| K193453 |
12/13/2019 |
TruDi Probe |
Acclarent, Inc. |
| K221037 |
04/07/2022 |
TruDi Shaver Blade |
Acclarent, Inc. |
| K150453 |
02/20/2015 |
TULA Iontophoresis System with Earset |
ACCLARENT, INC. |
| K143541 |
12/15/2014 |
Relieva SpinPlus Balloon Sinuplasty System |
ACCLARENT, INC. |
| K060974 |
04/10/2006 |
RELIENT NAVIGATION DEVICE |
ACCLARENT, INC. |
| K052198 |
08/12/2005 |
RELIEVA SINUS BALLOON INFLATION DEVICE |
ACCLARENT, INC. |
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