Company
Mentor Texas, LP.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
30recalls (8 in 12 months)
15recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LCJ | Tissue Expander And Accessories | 11 |
| FPK | Tubing, Fluid Delivery | 9 |
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | 2 |
| MRD | Mammary Sizer | 2 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 |
| FMF | Syringe, Piston | 1 |
| FTN | Plastic Surgery And Accessories Kit | 1 |
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | 1 |
| GAZ | Tubing, Noninvasive | 1 |
| MUU | System, Suction, Lipoplasty | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2026 | Mentor Texas LP SYRINGE LUER LOK 10CC-200/BOX
BD Product Code: 302995
Mentor Product Code: B9604
Syringe, Piston Open, Classified |
FMF | K110771 |
| Mar 27, 2026 | Mentor Texas, LP. Artoura Breast Tissue Expanders
Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH
Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc Open, Classified |
LCJ | K161176 |
| Mar 27, 2026 | Mentor Texas, LP. Artoura Breast Tissue Expanders
Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H
Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc Open, Classified |
LCJ | K161176 |
| Mar 27, 2026 | Mentor Texas, LP. Artoura Breast Tissue Expanders
Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH
Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 53 Open, Classified |
LCJ | K150777 |
| Mar 27, 2026 | Mentor Texas, LP. CPX 4 US Breast Tissue Expanders with Suture Tabs
Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH
Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc Open, Classified |
LCJ | K241918 |
| Mar 27, 2026 | Mentor Texas, LP. CPX 4 US Breast Tissue Expanders with Suture Tabs
Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH
Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 5 Open, Classified |
LCJ | K241918 |
| Mar 27, 2026 | Mentor Texas, LP. CPX 4 US Breast Tissue Expanders with Suture Tabs
Reference Numbers: SCPX-157LH
Smooth Low Height Tissue Expander, 650cc Open, Classified |
LCJ | K241918 |
| Mar 27, 2026 | Mentor Texas, LP. CPX 4 US Breast Tissue Expanders with Suture Tabs
Reference Numbers: 354-9113, 3549313, 354-9314
SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc) Open, Classified |
LCJ | K130813 |
| Sep 30, 2021 | Mentor Texas, LP. 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 siz Open, Classified |
FWM | None listed |
| May 11, 2017 | Mentor Texas, LP. Mentor Smooth Round SPECTRUM Post-
Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048 Terminated |
FWM | None listed |
| Sep 10, 2016 | Mentor Texas, LP. CPX4 Breast Tissue Expander 650 cc
:
Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect pr Terminated |
LCJ | K130813 |
| Sep 10, 2016 | Mentor Texas, LP. 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 p Terminated |
LCJ | K150777 |
| Sep 7, 2016 | Mentor Texas, LP. MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313
The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for Terminated |
LCJ | K130813 |
| Sep 7, 2016 | Mentor Texas, LP. MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312
The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for Terminated |
LCJ | K130813 |
| Jul 1, 2016 | Mentor Texas, LP. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Terminated |
FTR | None listed |
| Jan 13, 2015 | Mentor Texas, LP. MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer. Terminated |
MRD | K062421 |
| Sep 4, 2014 | Mentor Texas, LP. 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 Terminated |
MRD | K010709 |
| Dec 12, 2008 | Mentor Texas, Inc Mentor Aseptic Transfer Set, Cat. #350-8400 (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 Be Terminated |
GAZ | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Contour Genesis Aspiration Tubing, 12'; Part Number CG-PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
BYY | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Contour Genesis Inf/IR Tubing; Part Number CG-UT; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Y Tubing Set, 9'; 10/box; Part Number LAM-Y; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 5, 2008 | Mentor Texas, Inc Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038. Terminated |
FPK | None listed |
| Sep 20, 2007 | Mentor Texas, Inc 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530. Terminated |
MUU | K041058 |
| Jul 20, 2004 | Mentor Texas, Inc Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas Terminated |
FTN | None listed |