510(k) K112056 ยท GDW Staple, Implantable
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
| Applicant | Ethicon Endo-Surgery, LLC, Cincinnati OH, US |
| Decision | Substantially Equivalent, Dec 19, 2011 |
| Received | Jul 19, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2013 | Ethicon Endo-Surgery Inc ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid.
The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.