Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005423519

FEI Number

3006165545

Entity Name

Mentor Texas LP

City/State/Country

Coppell, TX, US

Establishment Address

555 Airline Drive, Coppell, TX 75019, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

MENTOR Texas, LP (Owner Number: 2125050)

Owner / Operator Contact Address

3041 Skyway Cir N, --, Irving, TX 75038, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152496

PMA Number

N/A

All Registered Proprietary Names

Inspira Air Balloon Dilation System MENTOR MemoryGel Enhance Single Use Gel Sizer Relieva Luma Sinus Illumination System Relieva Luma Sentry Sinus Illumination System Relieva Vortex 2 Next Generation Balloon Dilation System Relieva Ultirra Sinus Balloon Catheter Relieva Flex Guide Catheter Sinus Guide Catheters Sinus Guidewire Relieva Sidekick LP Sidekick Scout® Multi-Sinus Dilation System ACCLARENT SE Inflation Device Circa Artoura Breast Tissue Expander Contour Profile Tissue Expander (CPX) SpinPlus Artoura Breast Tissue Expanders With Smooth Surface Inspira Air Balloon Dilation System MemoryGel Resterilizable Gel Sizers Mentor CPX 4 PLUS Enhance Breast Tissue Expanders Saline Implants Spectrum Saline Implants Siltex Contour Profile Saline Implants CPX4 Breast Tissue Expander 1445cc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2015-09-10
MRD	Mammary Sizer	Unknown	Class U	N/A	2025-02-12
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2015-12-15
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2015-12-15
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2021-02-18
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-02-18
PNZ	Eustachian Tube Balloon Dilation Device	Ear, Nose, Throat	Class 2	874.4180	2021-02-18
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2015-09-10
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2015-09-10
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2016-09-26
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2015-12-15
KAX	Punch, Ethmoid	Ear, Nose, Throat	Class 1	874.4420	2016-01-12
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2015-04-29
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2008-03-07
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2016-01-12
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2016-05-31
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2015-09-10
MRD	Mammary Sizer	Unknown	Class U	N/A	2008-03-07
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2025-02-12
FWM	Prosthesis, Breast, Inflatable, Internal, Saline	General, Plastic Surgery	Class 3	878.3530	2008-03-07
FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled	General, Plastic Surgery	Class 3	878.3540	2008-02-15
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2016-02-29

Official Correspondent

Kristi Bodin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MENTOR Texas, LP

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1645337	MENTOR	IRVING, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
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
K161483	Stradis Healthcare	Unger Quad Injector	2016-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-04	N/A	3	McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005423519. Last updated year: 2026. Please use registration number 3005423519 when referencing this establishment in official correspondence.