510(k) K223592 · FGE Stents, Drains And Dilators For The Biliary Ducts
Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Dec 29, 2022 |
| Received | Dec 1, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223592
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | Boston Scientific Corporation NaviFlex LW Pusher;
Advx Panc. Stent 4/5F;
Material Number (UPN): M00535030; Open, Classified |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.