Company · US
Acclarent, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (1 in 12 months)
15recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LRC | Instrument, Ent Manual Surgical | 14 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 13 |
| KTI | Bronchoscope Accessory | 10 |
| KAM | Cannula, Sinus | 9 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 4 |
| PNZ | Eustachian Tube Balloon Dilation Device | 4 |
| EGJ | Device, Iontophoresis, Other Uses | 3 |
| ETD | Tube, Tympanostomy | 2 |
| QGK | Balloon, Nasal Airway | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 19, 2026 | K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System Acclarent, Inc. | PNZ |
| Dec 13, 2023 | K230742 | ACCLARENT AERA Eustachian Tube Dilation System Acclarent, Inc. | PNZ |
| Jul 21, 2023 | K231862 | TruDi® Navigation System V3 (FG-2000-00) Acclarent, Inc. | PGW |
| Jul 20, 2022 | K221037 | TruDi Shaver Blade Acclarent, Inc. | PGW |
| Aug 27, 2020 | K201115 | Next Generation Balloon Dilation System Acclarent, Inc. | LRC |
| Aug 12, 2020 | K201174 | TruDi Curette Acclarent, Inc. | PGW |
| Mar 23, 2020 | K193453 | TruDi Probe Acclarent, Inc. | PGW |
| May 3, 2019 | K190532 | TruDi NAV Wire Acclarent, Inc. | PGW |
| May 3, 2019 | K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter Acclarent, Inc. | LRC |
| Apr 19, 2019 | K183090 | Relieva Tract Balloon Dilation System Acclarent, Inc. | QGK |
| Jul 20, 2018 | K180948 | TruDi NAV Suction Instruments Acclarent, Inc. | PGW |
| Mar 10, 2018 | K173628 | Acclarent ENT Navigation System Acclarent, Inc. | PGW |
| Jan 16, 2018 | K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System Acclarent, Inc. | PNZ |
| Sep 5, 2017 | K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System Acclarent, Inc. | LRC |
| Oct 24, 2016 | K161698 | Relieva UltirraNav Sinus Balloon Catheter Acclarent, Inc. | LRC |
| Oct 24, 2016 | K161697 | Acclarent NavWire Sinus Navigation Guidewire Acclarent, Inc. | PGW |
| Sep 16, 2016 | DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation System Acclarent, Inc. | PNZ |
| Feb 12, 2016 | K153341 | Relieva Scout Multi-Sinus Dilation System Acclarent, Inc. | LRC |
| May 20, 2015 | K150453 | TULA Iontophoresis System with Earset Acclarent, Inc. | EGJ |
| Apr 22, 2015 | K143541 | Relieva SpinPlus Balloon Sinuplasty System Acclarent, Inc. | LRC |
| Apr 7, 2015 | K150172 | ACCLARENT SE Inflation Device Acclarent, Inc. | LRC |
| Apr 24, 2014 | K132433 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE Acclarent, Inc. | EOB |
| Feb 20, 2014 | K140160 | RELIEVA SCOUT SINUS DILATION SYSTEM Acclarent, Inc. | LRC |
| Nov 5, 2012 | K120280 | RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM Acclarent, Inc. | LRC |
| Oct 11, 2011 | K111875 | RELIEVA SPIN SINUS DILATION SYSTEM Acclarent, Inc. | LRC |
| Oct 7, 2011 | K110687 | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) Acclarent, Inc. | KAM |
| Aug 22, 2011 | K111254 | RELIEVA SOLO ELITE SINUS BALLOON CATHETER Acclarent, Inc. | LRC |
| Jun 16, 2011 | K110636 | TULA IONTOPHORESIS SYSTEM Acclarent, Inc. | EGJ |
| May 27, 2011 | K110097 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE Acclarent, Inc. | EOB |
| Apr 1, 2011 | K103595 | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM Acclarent, Inc. | ETD |
| Mar 31, 2011 | K110218 | INSPIRA AIR BALLOON DILATION SYSTEM Acclarent, Inc. | KTI |
| Jan 6, 2011 | K100577 | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE Acclarent, Inc. | EOB |
| Mar 3, 2010 | K093594 | MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER Acclarent, Inc. | KAM |
| Jun 12, 2009 | K090660 | AIRWAY BALLOON CATHETER INFLATION DEVICE Acclarent, Inc. | KTI |
| Jan 29, 2009 | K083574 | RELIEVA STRATUS MICROFLOW SPACER Acclarent, Inc. | KAM |
| Sep 19, 2008 | K082188 | TYMPANOSTOMY TUBE Acclarent, Inc. | ETD |
| Mar 19, 2008 | K072891 | SINUS SPACER Acclarent, Inc. | KAM |
| Mar 11, 2008 | K073041 | RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER Acclarent, Inc. | KAM |
| Mar 5, 2008 | K073276 | IONTOPHORESIS SYSTEM Acclarent, Inc. | EGJ |
| Sep 28, 2007 | K071845 | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A Acclarent, Inc. | KAM |
| Oct 24, 2006 | K063078 | MICROENDOSCOPE Acclarent, Inc. | EOB |
| Sep 15, 2006 | K062458 | ETHMOID SINUS SPACER Acclarent, Inc. | KAM |
| Aug 18, 2006 | K061903 | RELIEVA SINUS BALLOON CATHETER Acclarent, Inc. | LRC |
| May 5, 2006 | K060974 | RELIENT NAVIGATION DEVICE Acclarent, Inc. | KAM |
| Aug 31, 2005 | K052198 | RELIEVA SINUS BALLOON INFLATION DEVICE Acclarent, Inc. | LRC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2023 | Acclarent, Inc. TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 Open, Classified |
PGW | K192397 |
| Nov 12, 2021 | Acclarent, Inc. TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z Open, Classified |
PGW | K180948 |
| Mar 6, 2019 | Acclarent, Inc. TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 Terminated |
PGW | K180948 |
| Mar 6, 2019 | Acclarent, Inc. TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884 Terminated |
PGW | K180948 |
| Mar 6, 2019 | Acclarent, Inc. TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 Terminated |
PGW | K180948 |
| Jun 9, 2015 | Acclarent, Inc. RELIEVA FLEX Sinus Guide Catheter F-70.
Catalog number GC070RF.
Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.
. Terminated |
KAM | None listed |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 16 x 40 mm, Syringe volume 12 cc.
Dilation of airway tree. Terminated |
KTI | K090660 K110218 |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 14 x 40 mm, Syringe volume 12 cc.
Dilation of airway tree. Terminated |
KTI | K090660 K110218 |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 12 x 40 mm, Syringe volume 12 cc.
Dilation of airway tree. Terminated |
KTI | K090660 K110218 |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 10 x 40 mm, Syringe volume 12 cc.
Dilation of airway tree. Terminated |
KTI | K090660 K110218 |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 8.5 x 24 mm, Syringe volume 12 cc.
Dilation of airway tree. Terminated |
KTI | K090660 K110218 |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 7 x 24 mm, Syringe volume 6-8 cc.
Dilation of airway tree. Terminated |
KTI | K090660 K110218 |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 5 x 24 mm, Syringe volume 6-8 cc.
Dilation of airway tree. Terminated |
KTI | K090660 K110218 |
| Mar 1, 2012 | Acclarent, Inc. Inspira AIR Balloon Dilation System,
size 18 x 40;
Manufactured by Acclarent, Inc.
1525-G O'Brien Drive, Menlo Park, CA 94025
Product Usage: Dilation of airway tree. Terminated |
KTI | K110218 |
| Feb 24, 2006 | Acclarent Inc Acclarent brand Relieva Sinus Inflation Device Kit;
Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O Terminated |
LRC | None listed |