The following data is part of a premarket notification filed by Endogi Medical with the FDA for Endogi S-path Biliary Stent System.
| Device ID | K222627 |
| 510k Number | K222627 |
| Device Name: | EndoGI S-Path Biliary Stent System |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | EndoGI Medical 13 Wadi El Hadj Nazareth, IL |
| Contact | Omri Naveh |
| Correspondent | Bosmat Friedman ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, NC 28269 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-31 |
| Decision Date | 2022-09-28 |