FDA product code MBU: Single-Use Internal Condom
MBU is the FDA product code for single-use internal condom. It is a Class II device, regulated under 21 CFR 884.5340 and reviewed by the Obstetrics and Gynecology panel. Devices under MBU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code.
Definition
For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded.
Classification
| Field | Value |
|---|---|
| Device name | Single-Use Internal Condom |
| Device class | Class II |
| Regulation | 21 CFR 884.5340 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Recalls for MBU devices
openFDA lists no recalls for product code MBU.
Frequently asked questions
What is FDA product code MBU?
MBU is the FDA product code for single-use internal condom. It is a Class II device, regulated under 21 CFR 884.5340 and reviewed by the Obstetrics and Gynecology panel.
What device class is MBU?
Class II, regulation 21 CFR 884.5340. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MBU
- Run a recall and safety report across every MBU manufacturer
- Watch product code MBU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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