Product code
OTN: Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
FDA product code · Class II · Gastroenterology/Urology
Key facts
| Product code | OTN |
|---|---|
| Device | Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator |
| Device class | Class II |
| Regulation number | 878.3300 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database