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510(k) Data Aggregation
K Number
K220089Device Name
Disposable Polyp Snare
Manufacturer
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
Date Cleared
2022-09-22
(254 days)
Product Code
FDI, FGX
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Vedkang Medical Science and Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Polyp Snare is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The snare can be used with or without high-frequency current.
Device Description
The subject device is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract.
The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section.
The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current.
The shape of the loop includes oval, crescent, hexagonal, rhombus, dual-width oval, and polygonal. Users can choose the shape of the snare according to their preference and the characteristic of the lesion.
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K Number
K213914Device Name
Injection Needle
Manufacturer
Jiangsu Vedkang Medical Science and Technology Co.,Ltd
Date Cleared
2022-07-29
(226 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Vedkang Medical Science and Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
Device Description
The injection needle is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract, which consists of needle, connector tube, outer tube, outer tube, outer tube, protective sleeve, front handle, injection handle, front handle cover and boosting tube. The proposed device is used to puncture the target tissue where guided by the endoscope. The fluid is injected to the target through the proposed device by an injector which is connected the proposed device.
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