Company ยท US
Mpathy Medical Devices, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2009. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 2 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 2 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | 2 |
| OTP | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 12, 2009 | K092203 | OMNISURE URETHRAL SLING, MODEL OTK52 Mpathy Medical Devices, Ltd., GB | OTN |
| Aug 4, 2009 | K092207 | RESTORELLE POLYPROPYLENE MESH Mpathy Medical Devices, Inc., GB | OTP |
| Jul 14, 2009 | K091180 | MINITAPE URETHRAL SLING Mpathy Medical Devices, Ltd., GB | PAH |
| Mar 3, 2008 | K073647 | MINITAPE EXTRA URETHRAL SLING Mpathy Medical Devices, Ltd. | OTN |
| Feb 25, 2008 | K073646 | MINITAPE URETHRAL SLING Mpathy Medical Devices, Ltd. | PAH |
| Feb 6, 2006 | K053361 | MODIFICATION TO: MINIMESH POLYPROPYLENE MESH Mpathy Medical Devices, Ltd. | OTO |
| Nov 17, 2004 | K041632 | MINIMESH POLYPROPYLENE MESH Mpathy Medical Devices, Ltd. | OTO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||