The following data is part of a premarket notification filed by Motus Gi Medical Technologies Ltd. with the FDA for Pure Vu System.
| Device ID | K210981 |
| 510k Number | K210981 |
| Device Name: | Pure Vu System |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | Motus GI Medical Technologies Ltd. 22 Keren Ha'yesod Str. Tirat Carmel, IL 3902638 |
| Contact | Mark Pomeranz |
| Correspondent | Mark Pomeranz Motus GI Medical Technologies Ltd. 22 Keren Ha'yesod Str. Tirat Carmel, IL 3902638 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-01 |
| Decision Date | 2021-04-29 |