Data / Medical devices / United States / Mentor
Mentor: FDA-registered device maker in Irving, TX, United States, 18 510(k) clearances and 3 PMA approvals
Mentor is registered with the FDA (registration 1645337) in Irving, TX, United States. It lists 8 device types. The FDA files 18 510(k) clearances and 3 PMA approvals under its listings, the newest dated January 13, 2025. 12 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1645337
- FEI number
- 1000118360
- Address
- 3041 Skyway Circle North, Irving, TX, United States, 75038
- Owner or operator
- MENTOR Texas, LP (2125050)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 14, 2006
- Registered through
- 2026
- Brand names listed
- Artoura Breast Tissue Expander, Artoura Breast Tissue Expanders With Smooth Surface, Aseptic Transfer Kit, Byron Cannula and Hand Instruments, CPX4 Breast Tissue Expander 1445cc, Cannula, Contour Profile Tissue Expander (CPX), MENTOR MemoryGel Enhance Single Use Gel Sizer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Specification developer | accessdata.fda.gov |
| Mammary Sizer | MRD | U | Manufacturer | accessdata.fda.gov |
| Prosthesis, Breast, Inflatable, Internal, Saline | FWM | 3 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | FTR | 3 | Manufacturer | accessdata.fda.gov |
| System, Suction, Lipoplasty For Removal | QPB | 2 | Specification developer | accessdata.fda.gov |
| Tissue Expander And Accessories | LCJ | U | Manufacturer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 13, 2025 | K243271 | MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer | MRD | Substantially Equivalent | Mentor Worldwide, LLC | accessdata.fda.gov |
| January 12, 2025 | K243836 | Mentor CPX 4 PLUS Enhance Breast Tissue Expander | LCJ | Substantially Equivalent | Mentor Worldwide, LLC | accessdata.fda.gov |
| September 6, 2024 | K241552 | MENTOR MemoryGel Enhance Single Use Gel Sizer | MRD | Substantially Equivalent | Mentor Worldwide, LLC | accessdata.fda.gov |
| August 2, 2024 | K241918 | MENTOR CPX4 PLUS Enhance Breast Tissue Expander | LCJ | Substantially Equivalent | Mentor Worldwide, LLC | accessdata.fda.gov |
| September 25, 2018 | K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | LCJ | Substantially Equivalent | Mentor Worldwide, LLC | accessdata.fda.gov |
| May 23, 2016 | K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | LCJ | Substantially Equivalent | Mentor Worldwide, LLC | accessdata.fda.gov |
| February 19, 2016 | K152496 | CPX 4 Breast Tissue Expander | LCJ | Substantially Equivalent | Mentor Worldwide, LLC | accessdata.fda.gov |
| May 20, 2015 | K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE | MRD | Substantially Equivalent | Mentor Worldwide, LLC | accessdata.fda.gov |
| April 24, 2015 | K150777 | Artoura Breast Tissue Expander | LCJ | Substantially Equivalent | Mentor Worldwide, LLC | accessdata.fda.gov |
| April 11, 2013 | K130813 | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS | LCJ | Substantially Equivalent | Mentor Corp. | accessdata.fda.gov |
| October 10, 2006 | K062421 | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER | MRD | Substantially Equivalent | Mentor Corporation | accessdata.fda.gov |
| December 3, 2001 | K011500 | MENTOR CONTOUR PROFILE TISSUE EXPANDER | LCJ | Substantially Equivalent | Mentor Corp. | accessdata.fda.gov |
| April 23, 2001 | K010709 | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS | MRD | Substantially Equivalent | Mentor Corp. | accessdata.fda.gov |
| July 1, 1998 | K981215 | PSI-TEC LIPOSUCTION ASPIRATOR | QPB | Substantially Equivalent | Byron Medical | accessdata.fda.gov |
| June 30, 1998 | K981172 | LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES | QPB | Substantially Equivalent | Byron Medical | accessdata.fda.gov |
| February 10, 1998 | K974295 | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING | KGZ | Substantially Equivalent | Byron Medical | accessdata.fda.gov |
| August 17, 1984 | K842883 | RADOVAN TISSUE EXPANDER | LCJ | Substantially Equivalent | Mentor Corp. | accessdata.fda.gov |
| April 18, 1978 | K780417 | ASEPTIC TRANSFER SET | GAZ | Substantially Equivalent | Heyer Schulte Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 14, 2013 | P060028 | MENTOR MEMORYSHAPE BREAST IMPLANTS | FTR | 50 | October 23, 2026 | accessdata.fda.gov |
| November 17, 2006 | P030053 | MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS | FTR | 79 | October 23, 2026 | accessdata.fda.gov |
| May 10, 2000 | P990075 | MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES | FWM | 67 | October 23, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 18, 2026 | 98482 | Class II | Ongoing | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers:, 3549313, SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc) | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | accessdata.fda.gov |
| September 30, 2021 | 88868 | Class II | Ongoing | MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isoto | Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device. | accessdata.fda.gov |
| March 27, 2017 | 76868 | Class II | Terminated | Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code:, UDI/GTIN: 00081317002048 | Missing Dome Pack accessory. | accessdata.fda.gov |
| August 9, 2016 | 74899 | Class II | Terminated | Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The device | The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. | accessdata.fda.gov |
| August 9, 2016 | 74895 | Class II | Terminated | MENTOR 2" Tall Height TE With Sutures 350cc PN: The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or sub | Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc | accessdata.fda.gov |
| July 1, 2016 | 74565 | Class II | Terminated | Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. | The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. | accessdata.fda.gov |
| December 11, 2014 | 70042 | Class II | Terminated | MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer. | The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer. | accessdata.fda.gov |
| July 2, 2014 | 69022 | Class II | Terminated | EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertio | The device labeling is stamped with 330cc and the device is actually 380cc device. | accessdata.fda.gov |
| August 22, 2008 | 49522 | Not yet classified | Terminated | Mentor Aseptic Transfer Set, Cat. # (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes | The Mentor Aseptic Transfer Set contains a component, the BD 60mL Luer-Lok Syringe, which is under recall by Becton Dickinson due to a package integrity issue. | accessdata.fda.gov |
| April 21, 2008 | 47873 | Not yet classified | Terminated | Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038. | During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices. | accessdata.fda.gov |
| July 27, 2007 | 38623 | Not yet classified | Terminated | 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530. | Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x 30cm Hollow Bullet Tip Ultrasonic Probe, Catalog Number 5610-530. | accessdata.fda.gov |
| December 16, 2003 | 29132 | Not yet classified | Terminated | Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas | Device was distributed without the dome part accessory, part number 350-DOMPK | accessdata.fda.gov |
Compare with other makers
- All makers of Mammary Sizer
- All makers of System, Suction, Lipoplasty For Removal
- All makers of Tissue Expander And Accessories
- All makers of Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- All makers of Prosthesis, Breast, Inflatable, Internal, Saline
- All makers of Accessories, Catheter
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.