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510(k) Data Aggregation
K Number
K161757Device Name
Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads
Manufacturer
VICTOR MEDICAL INSTRUMENTS CO.,LTD.
Date Cleared
2016-12-05
(161 days)
Product Code
GDW, GAG
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
VICTOR MEDICAL INSTRUMENTS CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single Use Endoscopic Linear Cutters and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The Single Use Curved Cutters are intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and sketal muscle), gynecologic, urologic, and thoracic surgical procedures.
The Single Use Circular staplers have application throughout the alimentary tract for the creation of end-toside and side-to-side anastomoses in abdominal or thoracic surgeries.
The Single Use Linear Staplers and Reloads have application in transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The Single Use Linear Cutters and Reloads have application in abdominal, gynecological, thoracic and pediatic surgery transection, resection and the creation of anastomoses.
The Single Use Hemorrhoidal Staplers have application for general treatment of hemorrhoids.
Device Description
The Single Use Curved Cutters place four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 4.8mm staple size.
Single Use Circular staplers place 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 are available in 25mm, 27mm and 33mm three specifications. The staple is available in two specifications which are 4.8mm, 5.2mm to be used per different thickness of the tissue.
Single Use Endoscopic Linear Cutters and Reloads place two, triple-staggered rows of progressive titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in three staple sizes to accommodate various tissue thicknesses: 2mm-3mm, 4mm-5mm. The device may be reloaded and fired up to 8 times in a single procedure.
Single Use Linear Staplers and Reloads place a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm and 100mm staple line length for use in various applications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 7 times for a total 8 firing in a single procedure.
Single Use Linear Cutters and Reloads place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 7 times for a total 8 firings in a single procedure.
Single Use Hemorrhoidal Staplers are a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 32mm, 34mm two specifications. The staple size is 4.0mm. It cannot be reloaded.
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