510(k) K160176 ยท GDW Staple, Implantable
Signia Stapler
| Applicant | Covidien, North Haven CT, US |
| Decision | Substantially Equivalent, Apr 26, 2016 |
| Received | Jan 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160176
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2023 | Covidien, LP Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA 60 ARTICULATING MED THICK SULU
, EGIA60AMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA45 CT AR MD THK REL, EGIA45CTAMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD
, SIG30AMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC
, SIG45CTAMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC
, SIG60CTAMT Open, Classified |
GDW | None listed |
| Dec 13, 2017 | Covidien LLC Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits)
The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.