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510(k) Data Aggregation
K Number
K093410Device Name
AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY
Manufacturer
SURGICAL DEVICES, A DIVSION OF TYCO HEALTHCARE
Date Cleared
2009-11-12
(10 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL DEVICES, A DIVSION OF TYCO HEALTHCARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Autosuture™ Endo GIA™ Staplers with Endo GIA™ Single Use Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
Device Description
This 510(k) shall describe a new Reload cartridge with Tri-Staple™ technology for use with the currently marketed Autosuture™ Endo GIA™ Stapler as described in the predicate submission K083519. The black Reload bears the identical design characteristics as the Reloads with Tri-Staple™ Technology described in the predicate submission with the exception that the staples sizes shall be 4.0, 4.5, and 5.0 mm for use in extra thick tissue. The black Reloads shall be made available in 45 mm and 60 mm lengths.
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