The following data is part of a premarket notification filed by Mpathy Medical Devices, Ltd. with the FDA for Omnisure Urethral Sling, Model Otk52.
| Device ID | K092203 |
| 510k Number | K092203 |
| Device Name: | OMNISURE URETHRAL SLING, MODEL OTK52 |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | MPATHY MEDICAL DEVICES, LTD. LONMAY ROAD Glasgow, GB G33 4el |
| Contact | Caroline Stretton |
| Correspondent | Caroline Stretton MPATHY MEDICAL DEVICES, LTD. LONMAY ROAD Glasgow, GB G33 4el |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-22 |
| Decision Date | 2009-08-12 |
| Summary: | summary |