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510(k) Data Aggregation
K Number
K193272Device Name
GTK Trocars
Manufacturer
Date Cleared
2020-07-09
(226 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou TK Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GTK Trocars has an application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments.
Device Description
The GTK Trocars has an application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments. The available model of the Trocar is model CT.
All the trocars have the similar structure. They are composed of cannula, stopcock, trocar cap, and obturator. The trocar cap has a universal seal which accommodates instruments of different diameters. The cannula has a valve which ensures the sealing performance.
The CT trocar consists of an obturator assembly and a cannula assembly. The obturator assembly can be assembled with the cannula assembly by indicator fitting. And Model CT includes CT bladeless trocar, CT optical trocar, and CT bladed trocar.
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