Cook Ireland, Ltd. · Class II · Cleared Jun 14, 2024
| K-number | K233079 |
| Device name | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) |
| Applicant | Cook Ireland, Ltd. |
| Product code | FGE |
| Device class | Class II |
| Decision date | Jun 14, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 876.5010 |
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