ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
FDA 510(k) clearance K070887 · decided 2007-05-25
Clearance details
- K-number
- K070887
- Device name
- ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
- Applicant
- Ethicon Endo-Surgery, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-03-30
- Decision date
- 2007-05-25
- Days to decision
- 56 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 |
|---|---|---|
| The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear C recall (Z-1627-2012) | Ethicon Endo-Surgery Inc | 2012-05-18 |
| ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CT recall (Z-3187-2011) | Ethicon Endo-Surgery Inc | 2011-09-12 |
| ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; recall (Z-1068-2011) | Ethicon Endo-Surgery Inc | 2011-02-15 |
| ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by recall (Z-0361-2011) | Ethicon Endo-Surgery Inc | 2010-11-15 |