easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)
FDA 510(k) clearance K143129 · decided 2015-01-29
Clearance details
- K-number
- K143129
- Device name
- easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)
- Applicant
- Ezisurg Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-10-31
- Decision date
- 2015-01-29
- Days to decision
- 90 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
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.