The following data is part of a premarket notification filed by Medinol Ltd. with the FDA for X-suit Nir Biliary Metallic Stent.
| Device ID | K150487 |
| 510k Number | K150487 |
| Device Name: | X-Suit NIR Biliary Metallic Stent |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDINOL LTD. KIRYAT ATIDIM, BUILDING 8 Tel Aviv, IL 6158101 |
| Contact | Michal Hershkovitz |
| Correspondent | H. Semih Oktay CARDIOMED DEVICE CONSULTANTS, LLC 5523 RESEARCH PARK DRIVE SUITE 360 Baltimore, MD 21228 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-25 |
| Decision Date | 2016-02-12 |