FDA product code OBY: Condom, Female, Animal Tissue
OBY is the FDA product code for condom, female, animal tissue. It is a Class III device, regulated under 21 CFR 884.5330 and reviewed by the Obstetrics and Gynecology panel. Devices under OBY reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes.
Classification
| Field | Value |
|---|---|
| Device name | Condom, Female, Animal Tissue |
| Device class | Class III |
| Regulation | 21 CFR 884.5330 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Recalls for OBY devices
openFDA lists no recalls for product code OBY.
Frequently asked questions
What is FDA product code OBY?
OBY is the FDA product code for condom, female, animal tissue. It is a Class III device, regulated under 21 CFR 884.5330 and reviewed by the Obstetrics and Gynecology panel.
What device class is OBY?
Class III, regulation 21 CFR 884.5330. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OBY
- Run a recall and safety report across every OBY manufacturer
- Watch product code OBY 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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