Product code
PBQ: Fixation, non-absorbable or absorbable, for pelvic use
FDA product code · Class II · Obstetrics/Gynecology
Key facts
| Product code | PBQ |
|---|---|
| Device | Fixation, non-absorbable or absorbable, for pelvic use |
| Device class | Class II |
| Regulation number | 884.4530 |
| Review panel | Obstetrics/Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Attaching suture or stapling ligaments of the pelvic floor. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 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