510(k) K260835 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ARCHIMEDES Biodegradable Stent (Medium)
| Applicant | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.), Charlotte NC, US |
| Decision | Substantially Equivalent, Jul 27, 2026 |
| Received | Mar 13, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260835
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.