K172057 is an FDA 510(k) clearance for the Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on March 9, 2018, 246 days after receiving the submission on July 6, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K172057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2017 |
| Decision Date | March 09, 2018 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |