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510(k) Data Aggregation
K Number
K150026Device Name
Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
Manufacturer
Date Cleared
2015-05-18
(131 days)
Product Code
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
ETHICON ENDO-SURGERY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS-Flex45 No-Knife Articulating Linear Stapler and reloads are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. They can be used with staple line buttressing material. The instrument may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Device Description
The Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter is a sterile, single patient use instrument that delivers staples while simultaneously dividing tissue between rows. The instruments provide a staple line that is approximately 45 mm long and a cut line that is approximately 41 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws.
The Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler is a sterile, single patient use instrument that delivers staples but does not divide tissue. The instruments provide a staple line that is approximately 45 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws.
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