Embryogen
510(k) K140317
Embryogen is a medical device (FDA Class II; FDA product code MQL, Media, Reproductive) made by Origio A/S, cleared under FDA 510(k) K140317 on 16 Jun 2014, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140317 | Date16 Jun 2014 | StatusActive |
Official records
- FDA 510(k) database K140317
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQL
- Device class
- Class II
- Regulation
- 21 CFR Part 884.6180
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K140317
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| EmbryoGen 12040003D | 12040003D | 00888937801453 | — | On the market |
| EmbryoGen 12040003M | 12040003M | 00888937029468 | — | On the market |
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