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510(k) Data Aggregation
K Number
K142577Device Name
PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
Manufacturer
B.J.Z.H.F. Panther Medical Equipment Co. Ltd.
Date Cleared
2015-06-11
(272 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
B.J.Z.H.F. Panther Medical Equipment Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PANTHER Endo Linear Cutter Stapler with Single Use Loading Units has 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.
Device Description
The proposed device. PANTHER Endo Linear Cutter Staplers with Single Use Loading Units (SULU) is sterile (ETO), single-patient-use surgical instruments, which has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two triple-staggered rows. The Endo Linear Cutter Stapler will accommodate any of the reloading unit with staple cartridge lengths of 30mm, 45mm, and 60mm and come in long or compact shaft lengths, and they may be reloaded and fired up to 25 times in a single procedure. The size of the staples is decided by selecting 2.0 mm, 2.5 mm, 3.5 mm, 4.0 mm or 4.8mm SULU.
The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.
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