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510(k) Data Aggregation
K Number
K210909Device Name
easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
Manufacturer
Date Cleared
2021-06-24
(87 days)
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 easyEndoTM Lite Linear Cutting Stapler and Loading Units for Single Use are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or mimimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
Device Description
The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 260mm, 350mm and 440mm three lengths. The device is available in four five sizes to accommodate various tissue thickness: 2.0mm, 2.5mm, 3.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 13 times in a single procedure.
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K Number
K183477Device Name
easyPPHTM Hemorrhoidal Stapler for Single Use
Manufacturer
Date Cleared
2019-02-11
(56 days)
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 easyPPHTM Hemorrhoidal Stapler for Single Use has application throughout the anal to perform surgical treatment of hemorhoidal disease.
Device Description
The easyPPH™ Hemorrhoidal Stapler for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 33mm length with 3.5mm staple size.
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K Number
K181657Device Name
easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
Manufacturer
Date Cleared
2019-02-01
(224 days)
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 easyLCTM Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses.
The easyCSTM Circular Stapler for Single Use has applications throughout the alimentary for end to side and side to side anastomoses.
Device Description
The easyLCTM Linear Cutter Staplers and Loading Units for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 60mm, 80mm length with reload in 2.5mm, 3.8mm and 4.8mm staple size to accommodate various tissue thicknesses. The device may be reloaded and fired up to 8 times in a single procedure.
The easyCS™ Circular Stapler for Single Use places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler is available in 21mm, 29mm, 31mm and 33mm five specifications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses.
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K Number
K172960Device Name
easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
Manufacturer
Date Cleared
2017-12-21
(86 days)
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 devices are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
Device Description
The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 70mm, 160mm three lengths. Reloads of easyEndoTM Linear Cutting Stapler and Loading Units for Single Use are available in three staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm and 4.8mm. Reloads of easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use are available in four staple sizes to accommodate various tissue thickness: 2.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.
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