Product code
OQY: Intrauterine tamponade balloon
FDA product code · Class II · Obstetrics/Gynecology
Key facts
| Product code | OQY |
|---|---|
| Device | Intrauterine tamponade balloon |
| 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 | No |
| Life-sustaining or life-supporting | No |
| Definition | provides temporary control or reduction of postpartum uterine bleeding |
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