Product code
MBU: Single-use internal condom
FDA product code · Class II · Obstetrics/Gynecology
Key facts
| Product code | MBU |
|---|---|
| Device | Single-use internal condom |
| Device class | Class II |
| Regulation number | 884.5340 |
| 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 | For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 1–9 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