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510(k) Data Aggregation
K Number
K193339Device Name
GTK Veress Needles
Manufacturer
Guangzhou T.K Medical Instrument Co., Ltd.
Date Cleared
2020-01-30
(59 days)
Product Code
HIF, FHO
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou T.K Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GTK Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Device Description
The structure of the GTK Veress Needles contain inner needle, outer needle, warning block, spring, handle and valve. It contains a spring-loaded blunt stylet mechanism, which is also the major principle mechanism of GTK Veress Needles to achieve the intended use. It is used to establish pneumoperitoneum prior to trocar and cannula insertion in laparoscopic procedures. The veress needle is connected to the insufflators with a luer connector. There are two models of veress needles: VN-120 and VN-150, with different lengths of needle bodies (120mm and 150mm). The GTK Veress Needles are for single use and are supplied sterile. The contact time is no more than 24 hours. The product is sterilized by Ethylene oxide. The manufacture date and expiry date are shown on the labeling. The GTK Veress Needles are only intended for use in a hospital setting/environment.
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