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510(k) Data Aggregation
K Number
K151714Device Name
Disposable Endoscope Valves Set A
Manufacturer
Date Cleared
2015-12-03
(161 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable anoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes a suction valve, an air/water valve, and a biopsy valve. This is a single-use device.
Device Description
Wilson's Disposable Endoscope Valves Set A collects three types of valve products into one package unit. Disposable Endoscope Valves Set A can make it convenient for the replacement of Air/Water Valves, Suction Valves, Biopsy Valve during an endoscopic procedure. And these three types' valves can realize their intended uses respectively.
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K Number
K142144Device Name
DISPOSABLE INJECTION NEEDLE
Manufacturer
Date Cleared
2015-01-15
(163 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Wilson disposable injection needle has been designed to be used with an endoscope to perform following therapy:
1. Endoscopic sclerotherapy within the esophagus, stomach, duodenum, small intestine, large intestine.
2. Endoscopic hemostasis within the esophagus, stomach, duodenum, small intestine, large intestine.
3. Endoscopic submucosal injection within esophagus, stomach, duodenum, small intestine, large intestine.
Device Description
The subjected Disposable Injection Needle is operated together with an endoscope to conduct an endoscopic injection for the treatment of esophageal and gastric varices and submucosal injection in the digestive tract, such as esophagus, stomach, duodenum, small intestine, large intestine.
The subjected device is primarily constituted of handle, tube and needle. The models include PN series, PM series and PM(H) series.
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