OYO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Culture, Intravaginal, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6165
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| INVOcell Intravaginal Culture System (K222932) | Invo Bioscience | 2023-06-22 |
| INVOcell (DEN150008) | Invo Bioscience | 2015-11-02 |
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Every clearance here is in the API, with alerts when new ones post.