FDA Registration
Active
🇺🇸 United States
Mentor Texas LP
Reg #: 3005423519
·
FEI: 3006165545
·
Expires 2026
Products
13
Proprietary Names
40
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- Mentor Texas LP
- Registration Number
- 3005423519
- FEI Number
- 3006165545
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 555 Airline Drive
- City
- Coppell
- State
- TX
- ZIP
- 75019
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090660
- PMA Number
- P990075
Owner / Operator
- Firm Name
- MENTOR Texas, LP
- Operator Number
- 2125050
- Address
- 3041 Skyway Cir N, --
- City
- Irving
- State
- TX
- Postal Code
- 75038
- Country
- US
- Correspondent
- Kristi Bodin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2015-09-10 |
| Mammary Sizer | MRD | Class U | Unknown | No | 2025-02-12 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2015-12-15 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2015-12-15 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2021-02-18 |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2021-02-18 |
| Eustachian Tube Balloon Dilation Device | PNZ | Class 2 | Ear, Nose, Throat | No | 2021-02-18 |
| Punch, Ethmoid | KAX | Class 1 | Ear, Nose, Throat | No | 2016-01-12 |
| Tissue Expander And Accessories | LCJ | Class U | Unknown | No | 2015-04-29 |
| Prosthesis, Breast, Inflatable, Internal, Saline | FWM | Class 3 | General, Plastic Surgery | No | 2008-03-07 |
| Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | FTR | Class 3 | General, Plastic Surgery | No | 2008-02-15 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2015-09-10 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2015-12-15 |
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
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
Sterile MemoryShape Resterilizable Gel Sizers
MemoryShape Breast Implants
Cyclops Multi-Angle Endoscope
Smooth Tissue Expanders
MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer
MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer
Saline Sizers
Aera Eustachian Tube Balloon Dilation System
Mentor CPX 4 Breast Tissue Expanders And Mentor CPX 4 With Suture Tabs Breast Tissue Expanders
Light Guide Cable Adapters
Relieva Luma Light Guide Cable 2
Acclarent Inflation Device
Relieva Scout Sinus Dilation System
Relieva Spin Balloon Sinuplasty System
Mentor CPX 4 Breast Tissue Expander with Smooth Surface
Establishment Types
Repack or Relabel Medical Device