The following data is part of a premarket notification filed by Endogi Medical, Ltd. with the FDA for Endogi Biliary Stent System.
| Device ID | K193600 |
| 510k Number | K193600 |
| Device Name: | EndoGI Biliary Stent System |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | EndoGI Medical, Ltd. 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005738205 | K193600 | 000 |