The following data is part of a premarket notification filed by Cook Ireland Ltd. with the FDA for Zimmon Pancreatic Stents/stent Sets, Geenen Pancreatic Stents/stent Sets, Pushing Catheter And Guiding Catheter, Johlin Pancreatic Wedge Stent And Introducer Set.
| Device ID | K172057 |
| 510k Number | K172057 |
| Device Name: | Zimmon Pancreatic Stents/Stent Sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter And Guiding Catheter, Johlin Pancreatic Wedge Stent And Introducer Set |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Cook Ireland Ltd. O' Halloran Road, National Technology Park, Limerick, IE |
| Contact | Orla Gunning |
| Correspondent | Orla Gunning Cook Ireland Ltd. O' Halloran Road, National Technology Park, Limerick, IE |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-06 |
| Decision Date | 2018-03-09 |
| Summary: | summary |