Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005172759

FEI Number

3005172759

Entity Name

ACCLARENT, INC.

City/State/Country

Irvine, CA, US

Establishment Address

7585 Irvine Center Dr, Irvine, CA 92618, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ACCLARENT, INC. (Owner Number: 9068915)

Owner / Operator Contact Address

7585 Irvine Center Drive, --, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TruDi NAVWIRE TruDi Navigation System Acclarent ENT Navigation System ACCLARENT PIVOT Balloon Dilation Systems Light Guide Cable Adapters Relieva Luma Light Guide Cable 2 TruDi Shaver Blade Relieva Luma Sentry Sinus Illumination System Relieva SpinPlus Balloon Sinuplasty System TruDi Navigation System Acclarent Inflation Device Cyclops Multi-Angle Endoscope TruDi NAV Cable TruDi NAV Suction Relieva Spin Balloon Sinuplasty System ACCLARENT SE Inflation Device Relieva Ultirra Sinus Balloon Catheter TruDi Navigation System Relieva Flex Guide Catheter Relieva Sidekick LP Acclarent Relieva Ultirra® Nav Sinus Balloon Catheter Acclarent AERA Eustachian Tube Balloon Dilation System Acclarent Navwire Sinus Navigation Guidewire Scout® Multi-Sinus Dilation System TruDi® Curette Acclarent AERA Eustachian Tube Balloon Dilation System TruDi Probe Acclarent ENT Navigation System Acclarent Relieva SpinPlus Nav Balloon Sinuplasty System Inspira Air Balloon Dilation System Relieva Circa Ethmoid Punch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-05-08
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-04-16
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-08-28
PNZ	Eustachian Tube Balloon Dilation Device	Ear, Nose, Throat	Class 2	874.4180	2020-08-28
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2020-08-28
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2012-01-18
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-08-15
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2022-08-15
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2012-01-13
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2015-12-14
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-04-16
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2005-05-20
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2012-01-13
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-10-09
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2012-01-13
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2015-06-09
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2012-01-13
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-04-16
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2012-01-13
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2016-11-15
PNZ	Eustachian Tube Balloon Dilation Device	Ear, Nose, Throat	Class 2	874.4180	2016-09-16
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-11-15
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2016-03-08
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-08-12
PNZ	Eustachian Tube Balloon Dilation Device	Ear, Nose, Throat	Class 2	874.4180	2026-06-12
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-05-26
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-04-16
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-01-26
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2018-01-26
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2009-07-29
KAX	Punch, Ethmoid	Ear, Nose, Throat	Class 1	874.4420	2015-09-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ACCLARENT, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K200041	Fiagon GmbH	FlexPointer 1.5 Single Use, FlexTube 3 Single Use	2020-03-10
K171761	Acclarent, Inc.	ACCLARENT AERA Eustachian Tube Balloon Dilation System	2018-01-16
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K964548	Linvatec Corp.	APEX UNIVERSAL DRIVE SYSTEM	1997-01-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005172759. Last updated year: 2026. Please use registration number 3005172759 when referencing this establishment in official correspondence.