The following data is part of a premarket notification filed by Endocontrol with the FDA for Viky Up.
| Device ID | K122820 |
| 510k Number | K122820 |
| Device Name: | VIKY UP |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | ENDOCONTROL 5 Avenue Du Grand Sablon La Tronche, FR 38700 |
| Contact | Huguel Carine |
| Correspondent | Huguel Carine ENDOCONTROL 5 Avenue Du Grand Sablon La Tronche, FR 38700 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-14 |
| Decision Date | 2013-06-18 |
| Summary: | summary |