Mentor
Irving, TX, US
MENTOR appears in FDA device records in Irving, TX. FDA records list 65 510(k) clearances between and , 84 PMA records and 2 registered establishments. As of , FDA records show 30 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Mentor carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Mentor Texas LPregistration, enforcement report, recall
510(k) clearance history
Showing 50 of 65FDA records hold 65 510(k) clearances for Mentor between 1977 and 2013. The busiest year on record is 1985, with 8. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 1 |
| 1982 | 1 |
| 1984 | 4 |
| 1985 | 8 |
| 1986 | 5 |
| 1987 | 2 |
| 1988 | 6 |
| 1989 | 3 |
| 1990 | 2 |
| 1991 | 5 |
| 1992 | 1 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 5 |
| 1999 | 1 |
| 2001 | 5 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 5 |
| 2006 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130813 | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS | LCJ | Substantially Equivalent | |
| K062421 | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER | MRD | Substantially Equivalent | |
| K053414 | MENTOR NOVASILK MESH | OTP | Substantially Equivalent | |
| K053296 | MENTOR ARIS SUPRAPUBIC SURGICAL KIT | OTN | Substantially Equivalent | |
| K052440 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | EZD | Substantially Equivalent | |
| K050008 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | EZD | Substantially Equivalent | |
| K050148 | MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT | OTN | Substantially Equivalent | |
| K042851 | MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT | OTN | Substantially Equivalent | |
| K040959 | MENTOR GENESIS PENILE PROSTHESIS | FAE | Substantially Equivalent | |
| K031767 | MENTOR OBTAPE TRANS-OBTURATOR TAPE | OTN | Substantially Equivalent | |
| K011493 | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY | KPT | Substantially Equivalent | |
| K011500 | MENTOR CONTOUR PROFILE TISSUE EXPANDER | LCJ | Substantially Equivalent | |
| K004005 | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) | QPB | Substantially Equivalent | |
| K010709 | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS | MRD | Substantially Equivalent | |
| K003873 | MENTOR SELF-CATH CLOSED SYSTEM | FCM | Substantially Equivalent | |
| K003784 | MENTOR SELF-CATH PLUS | EZL | Substantially Equivalent | |
| K993308 | MENTOR EVACARE VAGINAL PESSARIES | HHW | Substantially Equivalent | |
| K983065 | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM | LFL | Substantially Equivalent | |
| K981527 | MENTOR PATHWAY INTRODUCER/DILATOR | QPB | Substantially Equivalent | |
| K980483 | MENTOR SUSPEND SLING | FTL | Substantially Equivalent | |
| K980050 | MENTOR SKIN PROTECTION PAD | GCJ | Substantially Equivalent | |
| K974469 | MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL | HQC | Substantially Equivalent | |
| K970471 | MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) | LFL | Substantially Equivalent | |
| K963066 | MENTOR INJECTION PORT DETECTOR (IPD) | LCJ | Substantially Equivalent | |
| K962013 | MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT | MDA | Substantially Equivalent | |
| K945628 | CLEAR ADVANTAGE II | EXJ | Substantially Equivalent | |
| K922346 | FEMALE URINE SAMPLING DEVICE | FCN | Substantially Equivalent | |
| K912919 | MENTOR INFUSION LINE | KNY | Substantially Equivalent | |
| K913524 | SILICONE MALE EXTERNAL CATHETER | EXJ | Substantially Equivalent | |
| K912060 | MENTOR BLACK LIGHT INJECTION STENT SET | FAD | Substantially Equivalent | |
| K910790 | MENTOR LUBRICATING JELLY | KMJ | Substantially Equivalent | |
| K905484 | ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT | LCJ | Substantially Equivalent | |
| K894475 | MENTOR TISSUE EXPANDERS W/TDMAC COATING | LCJ | Substantially Equivalent | |
| K900371 | MENTOR MODIFIED MALLEABLE PENILE PROSTHESES | FAE | Substantially Equivalent | |
| K895285 | MENTOR DUCTAL CATHETERS | GBZ | Substantially Equivalent | |
| K890402 | MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) | FAE | Substantially Equivalent | |
| K884250 | RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) | LCJ | Substantially Equivalent | |
| K883023 | MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND | GDS | Substantially Equivalent | |
| K883303 | MENTOR RAPID-SPAN (TM) TISSUE EXPANDER | FZW | Substantially Equivalent | |
| K875038 | MENTOR UNISTENT URETERAL STENT SET | FAD | Substantially Equivalent | |
| K871313 | ULTRA-FRESH DEODORANT | GDS | Substantially Equivalent | |
| K873557 | MENTOR BLACK LIGHT URETERAL STENT SET | FAD | Substantially Equivalent | |
| K874690 | GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER | FFX | Substantially Equivalent | |
| K863439 | INTRAUTERINE HEMOSTASIS BALLOON STENT | KNA | Substantially Equivalent | |
| K870059 | MENTOR NIPPLE RECONSTRUCTION DEVICE | Substantially Equivalent | ||
| K863565 | MENTOR ALLOPLASTIC SPERMATOCELE | LQS | Substantially Equivalent | |
| K862539 | SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE | FAD | Substantially Equivalent | |
| K862049 | MENTOR FLAT-SPAN | LCJ | Substantially Equivalent | |
| K860517 | MENTOR CORPORAL DILATORS | FAE | Substantially Equivalent | |
| K860055 | MENTOR SINGLE COIL URINARY DIVERSION STENT SET | FAD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1645337 | 1000118360 | MENTOR | 3041 SKYWAY CIRCLE NORTH, IRVING, TX 75038 US | 2026 | |
| 3005423519 | 3006165545 | Mentor Texas LP | 555 Airline Drive, Coppell, TX 75019 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- KNYAccessories, Catheter, G-U
- GDSBag, Stomal
- KTIBronchoscope Accessory
- KPTCalibrator, Dose, Radionuclide
- KAMCannula, Sinus
- FEZCatheter And Tube, Suprapubic
- GBZCatheter, Cholangiography
- LJECatheter, Nephrostomy
- EZLCatheter, Retention Type, Balloon
- EZDCatheter, Straight
- EXJDevice, Incontinence, Urosheath Type, Sterile
- EZNDilator, Catheter, Ureteral
- PGWEar, Nose, And Throat Stereotaxic Instrument
- MDAElastomer, Silicone, For Scar Management
- PNZEustachian Tube Balloon Dilation Device
- FZWExpander, Surgical, Skin Graft
- LMHImplant, Dermal, For Aesthetic Use
- LRCInstrument, Ent Manual Surgical
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic
- MDMInstrument, Manual, Surgical, General Use
- LFLInstrument, Ultrasonic Surgical
- KARIrrigator, Sinus
- GCJLaparoscope, General & Plastic Surgery
- KMJLubricant, Patient
- MRDMammary Sizer
- FTLMesh, Surgical, Polymeric
- OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- EOBNasopharyngoscope (Flexible Or Rigid)
- HHWPessary, Vaginal
- FWMProsthesis, Breast, Inflatable, Internal, Saline
- FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- FAEProsthesis, Penile
- KAXPunch, Ethmoid
- EQHSource, Carrier, Fiberoptic Light
- LQSSpermatocele, Alloplastic
- FADStent, Ureteral
- FGEStents, Drains And Dilators For The Biliary Ducts
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- FFXSystem, Gastrointestinal Motility (Electrical)
- QPBSystem, Suction, Lipoplasty For Removal
- LCJTissue Expander And Accessories
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- GAZTubing, Noninvasive
- HQCUnit, Phacofragmentation
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter
Recall records
Showing 25 of 30| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2614-2026 | SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston | A single lot of expired syringes were distributed due to a distribution system control failure. | Class II | Open, Classified | |
| Z-1687-2026 | 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 | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Open, Classified | |
| Z-1686-2026 | 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, 750cc, 850cc | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Open, Classified | |
| Z-1685-2026 | Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc, | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Open, Classified | |
| Z-1684-2026 | 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 | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Open, Classified | |
| Z-1683-2026 | 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, 550cc, 650cc, 800cc | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Open, Classified | |
| Z-1682-2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Open, Classified | |
| Z-1681-2026 | 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) | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Open, Classified | |
| Z-0367-2022 | 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 isotonic saline before implantation. The implants are available with SILTEX Textured or smooth surface shells. Each implant is supplied sterile with a disposable fill tube and reflux valve. | 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. | Class II | Open, Classified | |
| Z-2070-2017 | Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048 | Missing Dome Pack accessory. | Class II | Terminated | |
| Z-2781-2016 | 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 procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months. | The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. | Class II | Terminated | |
| Z-2780-2016 | 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 devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months. | The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. | Class II | Terminated | |
| Z-2748-2016 | 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 temporary subcutaneous or submuscular implantation and are not intended for use beyond six months. | Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc | Class II | Terminated | |
| Z-2747-2016 | 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 temporary subcutaneous or submuscular implantation and are not intended for use beyond six months. | Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc | Class II | Terminated | |
| Z-2326-2016 | 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. | Class II | Terminated | |
| Z-0964-2015 | 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. | Class II | Terminated | |
| Z-2591-2014 | 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 insertion intraoperatively to evaluate the volume of the breast implant to be implanted. | The device labeling is stamped with 330cc and the device is actually 380cc device. | Class II | Terminated | |
| Z-0407-2009 | 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 Becton Dickinson, Franklin Lakes, NJ 07417). | 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. | Terminated | ||
| Z-1799-2008 | Contour Genesis Aspiration Tubing, 12'; Part Number CG-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. | Terminated | ||
| Z-1798-2008 | Contour Genesis Inf/IR Tubing; Part Number CG-UT; 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. | Terminated | ||
| Z-1797-2008 | Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; 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. | Terminated | ||
| Z-1796-2008 | Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; 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. | Terminated | ||
| Z-1795-2008 | Irrigation Tubing, 25'; Part Number 5120-25; 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. | Terminated | ||
| Z-1794-2008 | Y Tubing Set, 9'; 10/box; Part Number LAM-Y; 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. | Terminated | ||
| Z-1793-2008 | Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain