510(k) K233079 · FGE Stents, Drains And Dilators For The Biliary Ducts
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. GPSO
| Applicant | Cook Ireland, Ltd., Limerick, IE |
| Decision | Substantially Equivalent, Jun 14, 2024 |
| Received | Sep 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233079
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.