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.
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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