FDA Product Code
FDA Product Code OYO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.6165
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K222932 | INVOcell Intravaginal Culture System | Invo Bioscience | 2023-06-22 | Traditional | PDF ↗ |
| DEN150008 | INVOcell | Invo Bioscience | 2015-11-02 | Direct | — |
Product code OYO · Class II · Obstetrics/Gynecology. Data: openFDA.