DEN150008 is an FDA 510(k) submission for the INVOcell. This device is classified as a Culture, Intravaginal, Assisted Reproduction (Class II - Special Controls, product code OYO).
Submitted by Invo Bioscience (Medford, US). The FDA issued a Not Cleared (DENG) decision on November 2, 2015.
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 | DEN150008 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 23, 2015 |
| Decision Date | November 02, 2015 |
| Days to Decision | 252 days |
| Submission Type | Direct |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| 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. |