510(k) K243412 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ARCHIMEDES Biodegradable Pancreatic Stent
| Applicant | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.), Charlotte NC, US |
| Decision | Substantially Equivalent, Jul 16, 2025 |
| Received | Nov 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243412
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.