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510(k) Data Aggregation
K Number
K171561Device Name
Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload
Manufacturer
Date Cleared
2017-08-28
(90 days)
Product Code
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
Dextera Surgical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MicroCutter 5/80 Stapler and MicroCutter 30 White, Blue, and Curved Tip White and Blue Reloads are intended for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, resection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
The MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads may additionally be used in conjunction with open solid organ parenchymal dissection techniques on veins 4-5 mm in diameter and arteries 3-7 mm in diameter.
Device Description
Each MicroCutter 30 Reload contains two double rows of 316L stainless steel staples. The size of the MicroCutter 30 Blue Reload and MicroCutter 30 Curved Tip Blue Reload staple is compatible with tissue that can be easily compressed to 1.5mm. The size of the MicroCutter30 White Reload and MicroCutter 30 Curved Tip White Reload staple is compatible with tissue that can be easily compressed to 1.0mm. If tissue cannot comfortably compress to the Maximum Tissue Thickness listed for each reload, or easily compresses to less than the Maximum Tissue Thickness listed for each reload, the tissue is contraindicated as it may be too thick or too thin for the selected staple size. The cut length of the staple line is 28.0mm (1.10in) and the staple line length is 30mm long. The MicroCutter 30 Reloads are deployed using the Dextera MicroCutter 5/80TM Stapler. The MicroCutter 5/80 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows.
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