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510(k) Data Aggregation
K Number
K200769Device Name
Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
Manufacturer
Wilson Instruments (SHA) Co., LTD
Date Cleared
2021-01-06
(287 days)
Product Code
ODC, PRE
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Wilson Instruments (SHA) Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
- Disposable Air/Water Valves: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
- Disposable Suction Valves: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
- Disposable Biopsy Valves: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
- Disposable Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve. This is a single-use device.
- Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow.
- Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
Device Description
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports of Pentax GI Video Endoscopes to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve, an air/water valve.
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