510(k) K191070 ยท GDW Staple, Implantable
Signia Small Diameter Reloads
| Applicant | Covidien, North Haven CT, US |
| Decision | Substantially Equivalent, Sep 4, 2019 |
| Received | Apr 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191070
| 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 |
| Nov 7, 2025 | Covidien, LP Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin);
BOX LOBECTOMIA VATS 3D;
CFN: BOX06170V4; Open, Classified |
GDW | None listed |
| Apr 1, 2024 | Covidien, LP Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT Open, Classified |
GDW | None listed |
| Apr 1, 2024 | Covidien, LP Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT Open, Classified |
GDW | None listed |
| Mar 4, 2021 | Covidien, LP Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long
Item Code: SIGSDL45CTVT Terminated |
GDW | None listed |
| Mar 4, 2021 | Covidien, LP Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short
Item Code: SIGSDS30CTV Terminated |
CDW | None listed |
| Mar 4, 2021 | Covidien, LP Covidien Signia Small Diameter Curved Tip Intelligent Reload
30 mm Vascular/Thin 8 mm - Short
Item Code:SIGSDS30CTVT Terminated |
CDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.