ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
FDA 510(k) clearance K141952 · decided 2014-11-24
Clearance details
- K-number
- K141952
- Device name
- ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
- Applicant
- Ethicon Endo-Surgery, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-18
- Decision date
- 2014-11-24
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product c recall (Z-1746-2025) | Ethicon Endo-Surgery Inc | 2025-05-20 |
| ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The ins recall (Z-1641-2015) | Ethicon Endo-Surgery Inc | 2015-05-21 |