510(k) K173270 ยท GDW Staple, Implantable
Tri-Staple 2.0 Reinforced Reload
| Applicant | Covidien, North Haven CT, US |
| Decision | Substantially Equivalent, Feb 20, 2018 |
| Received | Oct 12, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173270
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2024 | Covidien, LP Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal,
gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis
Model: SIGTR Open, Classified |
GDW | None listed |
| Mar 23, 2021 | Covidien Llc Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thorac Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.