Product code
OWT: Mesh, surgical, absorbable, abdominal hernia
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | OWT |
|---|---|
| Device | Mesh, surgical, absorbable, abdominal hernia |
| Device class | Class II |
| Regulation number | 878.3300 |
| Review panel | General & Plastic Surgery |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | For reinforcement of soft tissue where weakness exists during hernia repair. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- None 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