Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

46 results for "Acclarent, Inc."
1–24 of 46
Search insights Median review: 103d Cleared: 98% Top manufacturer: Acclarent, Inc. Lead specialty: Ear, Nose, Throat
Cleared Feb 19, 2026
Acclarent AERA Eustachian Tube Balloon Dilation System
K253612 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 93d
Cleared Dec 13, 2023
ACCLARENT AERA Eustachian Tube Dilation System
K230742 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 271d
Cleared Jul 21, 2023
TruDi® Navigation System V3 (FG-2000-00)
K231862 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 28d
Cleared Jul 20, 2022
TruDi Shaver Blade
K221037 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 104d
Cleared Aug 27, 2020
Next Generation Balloon Dilation System
K201115 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 122d
Cleared Aug 12, 2020
TruDi Curette
K201174 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 103d
Cleared Mar 23, 2020
TruDi Probe
K193453 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 101d
Cleared Jan 30, 2020
TruDi Navigation System
K192397 · PGW
Biosense Webster
Ear, Nose, Throat · 149d
Cleared May 03, 2019
TruDi NAV Wire
K190532 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 60d
Cleared May 03, 2019
RELIEVA ULTIRRA Sinus Balloon Catheter
K190525 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 60d
Cleared Apr 19, 2019
Relieva Tract Balloon Dilation System
K183090 · QGK
Acclarent, Inc.
Ear, Nose, Throat · 164d
Cleared Jul 20, 2018
TruDi NAV Suction Instruments
K180948 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 100d
Cleared Mar 10, 2018
Acclarent ENT Navigation System
K173628 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 106d
Cleared Jan 16, 2018
ACCLARENT AERA Eustachian Tube Balloon Dilation System
K171761 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 216d
Cleared Sep 05, 2017
Relieva SpinPlus Nav Balloon Sinuplasty System
K171687 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 90d
Cleared Oct 24, 2016
Relieva UltirraNav Sinus Balloon Catheter
K161698 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 126d
Cleared Oct 24, 2016
Acclarent NavWire Sinus Navigation Guidewire
K161697 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 126d
Not Cleared Sep 16, 2016
Acclarent Aera Eustachian Tube Balloon Dilation System
DEN150056 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 284d
Cleared Feb 12, 2016
Relieva Scout Multi-Sinus Dilation System
K153341 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 85d
Cleared May 20, 2015
TULA Iontophoresis System with Earset
K150453 · EGJ
Acclarent, Inc.
Physical Medicine · 89d
Cleared Apr 22, 2015
Relieva SpinPlus Balloon Sinuplasty System
K143541 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 128d
Cleared Apr 07, 2015
ACCLARENT SE Inflation Device
K150172 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 71d
Cleared Apr 24, 2014
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 262d
Cleared Feb 20, 2014
RELIEVA SCOUT SINUS DILATION SYSTEM
K140160 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 29d