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510(k) Data Aggregation
K Number
K143129Device Name
easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)
Manufacturer
Date Cleared
2015-01-29
(90 days)
Product Code
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
EziSurg Medical Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The easyEndo® Linear Cutting Stapler and Loading Unit for Single Use have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomoses.
Device Description
The proposed devices, easyEndo® Linear Cutting Stapler and Loading Unit for Single Use, are sterilized and disposable surgical instruments, which have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomoses.
It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The easyEndo® Linear Cutting Stapler may be reloaded and fired no more than 25 times in a single procedure.
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