The following data is part of a premarket notification filed by Endo Tools Therapeutics S.a. with the FDA for Endomina System.
| Device ID | K211309 |
| 510k Number | K211309 |
| Device Name: | Endomina System |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | Endo Tools Therapeutics S.A. Rue Auguste Piccard 48 Gosselies, BE 6041 |
| Contact | Marine Rouyer |
| Correspondent | Marine Rouyer Endo Tools Therapeutics S.A. Rue Auguste Piccard 48 Gosselies, BE 6041 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2021-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05425029282698 | K211309 | 000 |
| 05425029282070 | K211309 | 000 |
| 05425029282117 | K211309 | 000 |