510(k) K222641 · GDW Staple, Implantable
Signia Small Diameter Reloads Including Regular (Round) Tip Version
| Applicant | Covidien, North Haven CT, US |
| Decision | Substantially Equivalent, Nov 29, 2022 |
| Received | Sep 1, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222641
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | Covidien, LP Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin);
CFN: SIGSDL45CTVT; Open, Classified |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.