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510(k) Data Aggregation
K Number
K233263Device Name
Disposable Trocars
Manufacturer
Hangzhou Kangji Medical Instrument Co., Ltd.
Date Cleared
2024-04-09
(193 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Kangji Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope.
Device Description
The Disposable Trocars includes Normal trocars (model A), Balloon trocars (model B), Thread trocars (model C) and Single-port trocars (model E). They are generally composed of cannula and obturator, with or without filter/cleaning ring/protector. The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope. If needed, the CO2 can be infused through the valve. The product is sterilized by Ethylene oxide and is a single-use product.
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K Number
K232401Device Name
Disposable Veress Needles
Manufacturer
Hangzhou Kangji Medical Instrument Co., Ltd.
Date Cleared
2023-12-14
(126 days)
Product Code
HIF
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Kangji Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable 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 opic procedures.
Device Description
The Disposable Veress Needles are composed of needle, inner core, handle and made of medical grade stainless steel, PC, PE, ABS, and Model II has a silicone sleeve on the handle. The device is packed in Tyvek dialysis bag with 4058B Tyvek dialysis paper and ESE film. The contact duration is less than 24 hours. The device is 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. The device is sterilized by EO and is intended for single-use only. The proposed device is available in a variety of needle lengths. There are two models for Disposable Veress needles: I, II. The difference between the two models is that the model II has a blue silicone sleeve outside the handle.
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