510(k) K223760 · GDW Staple, Implantable
ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Gree
| Applicant | Ethicon Endo-Surgery, Guaynabo PR, US |
| Decision | Substantially Equivalent, Mar 15, 2023 |
| Received | Dec 15, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223760
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2025 | Ethicon Endo-Surgery Inc ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80 Open, Classified |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.