K222932 is an FDA 510(k) clearance for the INVOcell Intravaginal Culture System. This device is classified as a Culture, Intravaginal, Assisted Reproduction (Class II - Special Controls, product code OYO).
Submitted by Invo Bioscience (Sarasota, US). The FDA issued a Cleared decision on June 22, 2023, 269 days after receiving the submission on September 26, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6165. Intravaginal Culture Of Human Gametes And Embryos. To Hold And Maintain Gametes And Developing Embryos Over The Duration Of The Intravaginal Culture Period..
| 510(k) Number | K222932 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2022 |
| Decision Date | June 22, 2023 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | OYO - Culture, Intravaginal, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6165 |
| Definition | Intravaginal Culture Of Human Gametes And Embryos. To Hold And Maintain Gametes And Developing Embryos Over The Duration Of The Intravaginal Culture Period. |