510(k) K141952 ยท GDW Staple, Implantable
ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
| Applicant | Ethicon Endo-Surgery, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Nov 24, 2014 |
| Received | Jul 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141952
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2025 | Ethicon Endo-Surgery Inc Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35 Open, Classified |
GDW | None listed |
| May 21, 2015 | Ethicon Endo-Surgery Inc ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip,
Product Usage:
The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic an Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.