510(k) K172361 ยท GDW Staple, Implantable
EEA Circular Stapler with Tri-Staple Technology
| Applicant | Covidien, Min Hang District, Shanghai, CN |
| Decision | Substantially Equivalent, Feb 16, 2018 |
| Received | Aug 4, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2018 | COVIDIEN LLC EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT
Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple sta Terminated |
GAG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.