ClearanceBrief
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

CodeDeviceRecords
LCJTissue Expander And Accessories11
FPKTubing, Fluid Delivery9
FWMProsthesis, Breast, Inflatable, Internal, Saline2
MRDMammary Sizer2
BYYTube, Aspirating, Flexible, Connecting1
FMFSyringe, Piston1
FTNPlastic Surgery And Accessories Kit1
FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1
GAZTubing, Noninvasive1
MUUSystem, Suction, Lipoplasty1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 26, 2026Mentor Texas LP
SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
Open, Classified
FMFK110771
Mar 27, 2026Mentor 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
LCJK161176
Mar 27, 2026Mentor 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
LCJK161176
Mar 27, 2026Mentor 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
LCJK150777
Mar 27, 2026Mentor 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
LCJK241918
Mar 27, 2026Mentor 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
LCJK241918
Mar 27, 2026Mentor Texas, LP.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Open, Classified
LCJK241918
Mar 27, 2026Mentor 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
LCJK130813
Sep 30, 2021Mentor 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
FWMNone listed
May 11, 2017Mentor Texas, LP.
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Terminated
FWMNone listed
Sep 10, 2016Mentor 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
LCJK130813
Sep 10, 2016Mentor 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
LCJK150777
Sep 7, 2016Mentor 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
LCJK130813
Sep 7, 2016Mentor 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
LCJK130813
Jul 1, 2016Mentor Texas, LP.
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
Terminated
FTRNone listed
Jan 13, 2015Mentor Texas, LP.
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Terminated
MRDK062421
Sep 4, 2014Mentor 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
MRDK010709
Dec 12, 2008Mentor 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
GAZNone listed
Sep 5, 2008Mentor Texas, Inc
Contour Genesis Aspiration Tubing, 12'; Part Number CG-PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
Terminated
BYYNone listed
Sep 5, 2008Mentor Texas, Inc
Contour Genesis Inf/IR Tubing; Part Number CG-UT; distributed by Mentor Texas, LP, Irving, TX 75038.
Terminated
FPKNone listed
Sep 5, 2008Mentor Texas, Inc
Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
Terminated
FPKNone listed
Sep 5, 2008Mentor 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
FPKNone listed
Sep 5, 2008Mentor Texas, Inc
Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX 75038.
Terminated
FPKNone listed
Sep 5, 2008Mentor Texas, Inc
Y Tubing Set, 9'; 10/box; Part Number LAM-Y; distributed by Mentor Texas, LP, Irving, TX 75038.
Terminated
FPKNone listed
Sep 5, 2008Mentor Texas, Inc
Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; distributed by Mentor Texas, LP, Irving, TX 75038.
Terminated
FPKNone listed
Sep 5, 2008Mentor Texas, Inc
Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
Terminated
FPKNone listed
Sep 5, 2008Mentor Texas, Inc
Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving, TX 75038.
Terminated
FPKNone listed
Sep 5, 2008Mentor Texas, Inc
Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
Terminated
FPKNone listed
Sep 20, 2007Mentor Texas, Inc
5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.
Terminated
MUUK041058
Jul 20, 2004Mentor Texas, Inc
Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas
Terminated
FTNNone listed
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