Product code OYO
- Device name
- Culture, Intravaginal, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.6165
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K222932 | INVOcell Intravaginal Culture System | Invo Bioscience | 2023-06-22 |
| DEN150008 | INVOcell | Invo Bioscience | 2015-11-02 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00862190000358 | INVOcell Retention Device | INVO BIOSCIENCE, INC. | 2019-04-08 |
| 00862190000334 | INVOcell Culture Device | INVO BIOSCIENCE, INC. | 2017-05-09 |
| 00862190000341 | INVOcell Retention Device | INVO BIOSCIENCE, INC. | 2017-05-02 |
| 00862190000303 | INVOcell Culture Device | INVO BIOSCIENCE, INC. | 2016-09-23 |
| 00862190000310 | INVOcell Retention Device | INVO BIOSCIENCE, INC. | 2016-09-23 |
| 00862190000327 | INVOcell Holding Block | INVO BIOSCIENCE, INC. | 2016-09-23 |