Product code
PWJ: Instrumentation, surgical mesh, urogynecologic, stress urinary incontinence
FDA product code · Class II · Gastroenterology/Urology
Key facts
| Product code | PWJ |
|---|---|
| Device | Instrumentation, surgical mesh, urogynecologic, stress urinary incontinence |
| Device class | Class II |
| Regulation number | 884.4910 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | Obstetrics/Gynecology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 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