Company ยท US
Mentor Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2013. Name variants (Inc, Corp, punctuation) are merged.
65510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LCJ | Tissue Expander And Accessories | 9 |
| FAD | Stent, Ureteral | 8 |
| FAE | Prosthesis, Penile | 5 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 4 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 2 |
| EZD | Catheter, Straight | 2 |
| GDS | Bag, Stomal | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 |
| IPF | Stimulator, Muscle, Powered | 2 |
| LFL | Instrument, Ultrasonic Surgical | 2 |
| LJE | Catheter, Nephrostomy | 2 |
| MRD | Mammary Sizer | 2 |
| QPB | System, Suction, Lipoplasty For Removal | 2 |
| EZL | Catheter, Retention Type, Balloon | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 |
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | 1 |
| FEZ | Catheter And Tube, Suprapubic | 1 |
| FFX | System, Gastrointestinal Motility (Electrical) | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 2013 | K130813 | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS Mentor Corp. | LCJ |
| Oct 10, 2006 | K062421 | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER Mentor Corporation | MRD |
| Dec 27, 2005 | K053414 | MENTOR NOVASILK MESH Mentor Corp. | OTP |
| Dec 15, 2005 | K053296 | MENTOR ARIS SUPRAPUBIC SURGICAL KIT Mentor Corporation | OTN |
| Oct 11, 2005 | K052440 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER Mentor Corporation | EZD |
| Jun 3, 2005 | K050008 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER Mentor Corp. | EZD |
| Mar 9, 2005 | K050148 | MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT Mentor Corporation | OTN |
| Nov 9, 2004 | K042851 | MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT Mentor Corp. | OTN |
| Oct 29, 2004 | K040959 | MENTOR GENESIS PENILE PROSTHESIS Mentor Corp. | FAE |
| Jul 17, 2003 | K031767 | MENTOR OBTAPE TRANS-OBTURATOR TAPE Mentor Corp. | OTN |
| Oct 1, 2002 | K011493 | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY Mentor Corp. | KPT |
| Dec 3, 2001 | K011500 | MENTOR CONTOUR PROFILE TISSUE EXPANDER Mentor Corp. | LCJ |
| Oct 12, 2001 | K004005 | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) Mentor Corp. | QPB |
| Apr 23, 2001 | K010709 | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS Mentor Corp. | MRD |
| Mar 29, 2001 | K003873 | MENTOR SELF-CATH CLOSED SYSTEM Mentor Corp. | FCM |
| Mar 5, 2001 | K003784 | MENTOR SELF-CATH PLUS Mentor Corp. | EZL |
| Dec 13, 1999 | K993308 | MENTOR EVACARE VAGINAL PESSARIES Mentor Corp. | HHW |
| Dec 1, 1998 | K983065 | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM Mentor Corp. | LFL |
| Jul 9, 1998 | K981527 | MENTOR PATHWAY INTRODUCER/DILATOR Mentor Corp. | QPB |
| Apr 30, 1998 | K980483 | MENTOR SUSPEND SLING Mentor Corp. | FTL |
| Feb 27, 1998 | K980050 | MENTOR SKIN PROTECTION PAD Mentor Corp. | GCJ |
| Feb 24, 1998 | K974469 | MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL Mentor Corp. | HQC |
| Jul 17, 1997 | K970471 | MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) Mentor Corp. | LFL |
| Sep 27, 1996 | K963066 | MENTOR INJECTION PORT DETECTOR (IPD) Mentor Corp. | LCJ |
| Aug 22, 1996 | K962013 | MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT Mentor Corp. | MDA |
| Jul 6, 1995 | K945628 | CLEAR ADVANTAGE II Mentor Corp. | EXJ |
| Aug 14, 1992 | K922346 | FEMALE URINE SAMPLING DEVICE Mentor Corp. | FCN |
| Dec 13, 1991 | K912919 | MENTOR INFUSION LINE Mentor Corp. | KNY |
| Oct 4, 1991 | K913524 | SILICONE MALE EXTERNAL CATHETER Mentor Corp. | EXJ |
| Sep 27, 1991 | K912060 | MENTOR BLACK LIGHT INJECTION STENT SET Mentor Corp. | FAD |
| May 3, 1991 | K910790 | MENTOR LUBRICATING JELLY Mentor Corp. | KMJ |
| Feb 11, 1991 | K905484 | ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT Mentor Corp. | LCJ |
| Nov 26, 1990 | K894475 | MENTOR TISSUE EXPANDERS W/TDMAC COATING Mentor Corp. | LCJ |
| Nov 2, 1990 | K900371 | MENTOR MODIFIED MALLEABLE PENILE PROSTHESES Mentor Corp. | FAE |
| Oct 17, 1989 | K895285 | MENTOR DUCTAL CATHETERS Mentor Corp. | GBZ |
| Aug 3, 1989 | K890402 | MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) Mentor Corp. | FAE |
| Jun 12, 1989 | K884250 | RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) Mentor Corp. | LCJ |
| Sep 29, 1988 | K883023 | MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND Mentor Corp. | GDS |
| Aug 26, 1988 | K883303 | MENTOR RAPID-SPAN (TM) TISSUE EXPANDER Mentor Corp. | FZW |
| Mar 3, 1988 | K875038 | MENTOR UNISTENT URETERAL STENT SET Mentor Corp. | FAD |
| Mar 2, 1988 | K871313 | ULTRA-FRESH DEODORANT Mentor Corp. | GDS |
| Feb 11, 1988 | K873557 | MENTOR BLACK LIGHT URETERAL STENT SET Mentor Corp. | FAD |
| Feb 8, 1988 | K874690 | GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER Mentor Corp. | FFX |
| Jun 2, 1987 | K863439 | INTRAUTERINE HEMOSTASIS BALLOON STENT Mentor Corp. | KNA |
| Feb 24, 1987 | K870059 | MENTOR NIPPLE RECONSTRUCTION DEVICE Mentor Corp. | |
| Nov 19, 1986 | K863565 | MENTOR ALLOPLASTIC SPERMATOCELE Mentor Corp. | LQS |
| Sep 9, 1986 | K862539 | SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE Mentor Corp. | FAD |
| Jun 10, 1986 | K862049 | MENTOR FLAT-SPAN Mentor Corp. | LCJ |
| Mar 11, 1986 | K860517 | MENTOR CORPORAL DILATORS Mentor Corp. | FAE |
| Mar 11, 1986 | K860055 | MENTOR SINGLE COIL URINARY DIVERSION STENT SET Mentor Corp. | FAD |
Newest 50 of 65.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||