The following data is part of a premarket notification filed by Gi Supply with the FDA for Gi Supply Biliary Stent.
| Device ID | K031360 |
| 510k Number | K031360 |
| Device Name: | GI SUPPLY BILIARY STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | GI SUPPLY 25 VILLAGE HILL ROAD Willington, CT 06279 |
| Contact | Rob Whalen |
| Correspondent | Rob Whalen GI SUPPLY 25 VILLAGE HILL ROAD Willington, CT 06279 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-30 |
| Decision Date | 2003-09-24 |