Medical Device Manufacturer · US , Irvine , CA

Acclarent, Inc.

45 submissions · 44 cleared · Since 2005
45
Total
44
Cleared
1
Denied

Acclarent, Inc. — FDA 510(k) Submissions

Acclarent, Inc. has submitted 45 FDA 510(k) premarket notifications since 2005, of which 44 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Instrument, Ent Manual Surgical, Ear, Nose, And Throat Stereotaxic Instrument, Cannula, Sinus, Eustachian Tube Balloon Dilation Device, Nasopharyngoscope (flexible Or Rigid) . Use the specialty filter in the sidebar to narrow results.

45 devices
1–25 of 45
Acclarent AERA Eustachian Tube Balloon Dilation System
K253612 · PNZ Eustachian Tube Balloon... · Ear, Nose, Throat
Feb 2026 93d
ACCLARENT AERA Eustachian Tube Dilation System
K230742 · PNZ Eustachian Tube Balloon... · Ear, Nose, Throat
Dec 2023 271d
TruDi? Navigation System V3 (FG-2000-00)
K231862 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Jul 2023 28d
TruDi Shaver Blade
K221037 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Jul 2022 104d
Next Generation Balloon Dilation System
K201115 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Aug 2020 122d
TruDi Curette
K201174 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Aug 2020 103d
TruDi Probe
K193453 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Mar 2020 101d
RELIEVA ULTIRRA Sinus Balloon Catheter
K190525 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
May 2019 60d
TruDi NAV Wire
K190532 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
May 2019 60d
Relieva Tract Balloon Dilation System
K183090 · QGK Balloon, Nasal Airway · Ear, Nose, Throat
Apr 2019 164d
TruDi NAV Suction Instruments
K180948 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Jul 2018 100d
Acclarent ENT Navigation System
K173628 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Mar 2018 106d
ACCLARENT AERA Eustachian Tube Balloon Dilation System
K171761 · PNZ Eustachian Tube Balloon... · Ear, Nose, Throat
Jan 2018 216d
Relieva SpinPlus Nav Balloon Sinuplasty System
K171687 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Sep 2017 90d
Acclarent NavWire Sinus Navigation Guidewire
K161697 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Oct 2016 126d
Relieva UltirraNav Sinus Balloon Catheter
K161698 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Oct 2016 126d
Acclarent Aera Eustachian Tube Balloon Dilation System
DEN150056 · PNZ Eustachian Tube Balloon... · Ear, Nose, Throat
Sep 2016 284d
Relieva Scout Multi-Sinus Dilation System
K153341 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Feb 2016 85d
TULA Iontophoresis System with Earset
K150453 · EGJ Device, Iontophoresis,... · Physical Medicine
May 2015 89d
Relieva SpinPlus Balloon Sinuplasty System
K143541 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Apr 2015 128d
ACCLARENT SE Inflation Device
K150172 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Apr 2015 71d
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Apr 2014 262d
RELIEVA SCOUT SINUS DILATION SYSTEM
K140160 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Feb 2014 29d
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
K120280 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Nov 2012 280d
RELIEVA SPIN SINUS DILATION SYSTEM
K111875 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Oct 2011 102d
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