510(k) K083781 ยท GDW Staple, Implantable
EEA HEMORRHOID STAPLER & ACCESSORIES
| Applicant | Surgical Devices, A Global Business Unit Covidien, North Haven CT, US |
| Decision | Substantially Equivalent, Feb 4, 2009 |
| Received | Dec 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083781
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2018 | Covidien LLC EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515
Product Usage:
The EEA Hemorrhoid a Terminated |
GDW | None listed |
| Apr 9, 2018 | Covidien LLC EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560
Product Usage:
The EEA Hemorrhoid a Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.