The following data is part of a premarket notification filed by Anchora Medical, Ltd. with the FDA for Su2ura Approximation Device.
| Device ID | K201744 |
| 510k Number | K201744 |
| Device Name: | Su2ura Approximation Device |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | Anchora Medical, Ltd. Beit Tavor, Entrance 2, 3rd Floor I.z. Yokneam, IL 2069202 |
| Contact | Yoni Epstein |
| Correspondent | Eilat Ezra Duet-Medical Consulting Ltd. 10 HaAnafa Street POB536 Zur Moshe, IL 42810 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-25 |
| Decision Date | 2021-06-17 |