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Data / Medical devices / United States / Mentor Texas LP

Mentor Texas LP: FDA-registered device maker in Coppell, TX, United States, 27 510(k) clearances and 3 PMA approvals

Mentor Texas LP is registered with the FDA (registration 3005423519) in Coppell, TX, United States. It lists 13 device types. The FDA files 27 510(k) clearances and 3 PMA approvals under its listings, the newest dated January 13, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Mentor Texas LP
FDA registration number
3005423519
FEI number
3006165545
Address
555 Airline Drive, Coppell, TX, United States, 75019
Owner or operator
MENTOR Texas, LP (2125050)
Roles
Repackager or relabeler
First device listed
February 15, 2008
Registered through
2026
Brand names listed
ACCLARENT SE Inflation Device, Acclarent Inflation Device, Aera Eustachian Tube Balloon Dilation System, Artoura Breast Tissue Expander, Artoura Breast Tissue Expanders With Smooth Surface, CPX4 Breast Tissue Expander 1445cc, Circa, Contour Profile Tissue Expander (CPX) and more

Devices it lists

DeviceProduct codeClassRoleSource
Bronchoscope AccessoryKTI2Repackager or relabeleraccessdata.fda.gov
Cannula, SinusKAM1Repackager or relabeleraccessdata.fda.gov
Ear, Nose, And Throat Stereotaxic InstrumentPGW2Repackager or relabeleraccessdata.fda.gov
Eustachian Tube Balloon Dilation DevicePNZ2Repackager or relabeleraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Repackager or relabeleraccessdata.fda.gov
Irrigator, SinusKAR1Repackager or relabeleraccessdata.fda.gov
Mammary SizerMRDURepackager or relabeleraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Repackager or relabeleraccessdata.fda.gov
Prosthesis, Breast, Inflatable, Internal, SalineFWM3Repackager or relabeleraccessdata.fda.gov
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledFTR3Repackager or relabeleraccessdata.fda.gov
Punch, EthmoidKAX1Repackager or relabeleraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Repackager or relabeleraccessdata.fda.gov
Tissue Expander And AccessoriesLCJURepackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 13, 2025K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMRDSubstantially EquivalentMentor Worldwide, LLCaccessdata.fda.gov
January 12, 2025K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderLCJSubstantially EquivalentMentor Worldwide, LLCaccessdata.fda.gov
September 6, 2024K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMRDSubstantially EquivalentMentor Worldwide, LLCaccessdata.fda.gov
August 2, 2024K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderLCJSubstantially EquivalentMentor Worldwide, LLCaccessdata.fda.gov
August 27, 2020K201115Next Generation Balloon Dilation SystemLRCSubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
September 25, 2018K182335CPX 4 Breast Tissue Expander with Smooth SurfaceLCJSubstantially EquivalentMentor Worldwide, LLCaccessdata.fda.gov
September 16, 2016DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemPNZUnknownAcclarent, Inc.accessdata.fda.gov
May 23, 2016K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceLCJSubstantially EquivalentMentor Worldwide, LLCaccessdata.fda.gov
February 19, 2016K152496CPX 4 Breast Tissue ExpanderLCJSubstantially EquivalentMentor Worldwide, LLCaccessdata.fda.gov
February 12, 2016K153341Relieva Scout Multi-Sinus Dilation SystemLRCSubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
May 20, 2015K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMRDSubstantially EquivalentMentor Worldwide, LLCaccessdata.fda.gov
April 24, 2015K150777Artoura Breast Tissue ExpanderLCJSubstantially EquivalentMentor Worldwide, LLCaccessdata.fda.gov
April 22, 2015K143541Relieva SpinPlus Balloon Sinuplasty SystemLRCSubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
April 7, 2015K150172ACCLARENT SE Inflation DeviceLRCSubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
April 11, 2013K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSLCJSubstantially EquivalentMentor Corp.accessdata.fda.gov
November 5, 2012K120280RELIEVA SEEKER BALLOON SINUPLASTY SYSTEMLRCSubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
October 11, 2011K111875RELIEVA SPIN SINUS DILATION SYSTEMLRCSubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
August 22, 2011K111254RELIEVA SOLO ELITE SINUS BALLOON CATHETERLRCSubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
May 27, 2011K110097ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPEEOBSubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
March 31, 2011K110218INSPIRA AIR BALLOON DILATION SYSTEMKTISubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
June 12, 2009K090660AIRWAY BALLOON CATHETER INFLATION DEVICEKTISubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
September 28, 2007K071845RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100AKAMSubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
October 10, 2006K062421MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZERMRDSubstantially EquivalentMentor Corporationaccessdata.fda.gov
August 31, 2005K052198RELIEVA SINUS BALLOON INFLATION DEVICELRCSubstantially EquivalentAcclarent, Inc.accessdata.fda.gov
December 3, 2001K011500MENTOR CONTOUR PROFILE TISSUE EXPANDERLCJSubstantially EquivalentMentor Corp.accessdata.fda.gov
April 23, 2001K010709MENTOR STERILE SALINE MAMMARY VOLUME SIZERSMRDSubstantially EquivalentMentor Corp.accessdata.fda.gov
August 17, 1984K842883RADOVAN TISSUE EXPANDERLCJSubstantially EquivalentMentor Corp.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
June 14, 2013P060028MENTOR MEMORYSHAPE BREAST IMPLANTSFTR50October 23, 2026accessdata.fda.gov
November 17, 2006P030053MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTSFTR79October 23, 2026accessdata.fda.gov
May 10, 2000P990075MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESESFWM67October 23, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 28, 202698981Class IIOngoingSYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, PistonA single lot of expired syringes were distributed due to a distribution system control failure.accessdata.fda.gov

Compare with other makers

Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.