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510(k) Data Aggregation
K Number
K232244Device Name
Disposable Endoscope Valves System
Manufacturer
Date Cleared
2023-11-29
(124 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Changzhou Endoclean Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Endoscope Valves System includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapter and suction cleaning adapter
Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure.
Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water.
Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction.
Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.
Disposable AW Channel Cleaning Adapter, it is attached to the air/water cylinder of the endoscope, used for the air water channel pre-cleaning after the procedure.
Disposable Suction Cleaning Adapter also as one of accessories of the pre-cleaning endoscopic irrigation. The one end can be connected to the biopsy channel. the other end be connected to the water container. It is used to aspirate reprocessing fluids through the instrument channel port of the endoscope.
Device Description
The Endoscope Valves Systemare used to fit to multiple endoscope working channels/ports to enable anendoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials. It includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapterand suction cleaning adapter.All valvesare single-use device and packed individually in a sealed package or different types of valves products is packed into one package units. The valves are manufactured for use with OLYMPUS Endoscope Series, FUJIFILM Endoscope 700 Series, and Pentax 90 series endoscope.Some valvemay besold as both sterileand non-sterile.
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K Number
K221310Device Name
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
Manufacturer
Date Cleared
2022-10-07
(155 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Changzhou Endoclean Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Endoscopic Clean Connecting Tubes includes five subsets as below, they are intended to o provide sterile water and/ or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healthcare professional only. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.
The Endoscopic CO2 Source Tubing is intended to be used with a CO2 insufflator along with Clean Cap or Hybrid Irrigation Tubing to supply CO2 to a GI endoscope during GI endoscopic procedures.
Device Description
The proposed device includes two (2) categories:
- Endoscopic Clean Connecting Tubes
- Endoscopic CO2 Source Tubing
The proposed device, Endoscopic Clean Connecting Tubes, is to connect an air/ CO2 source, a sterile water source (water bottle), and an endoscope to supply air/ CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.
The Endoscopic Clean Connecting Tubes includes five (5) subsets:
- Irrigation Tube;
- Clean Cap
- Clean Cap with CO2 Source Tube
- Hybrid Irrigation Tubing
- Hybrid Irrigation Tubing With CO2 source tube
The Endoscopic CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope. It is composed of one female luer connector, one male luer connector, one rigid tube and air/gas filter. The air/gas filter can filter particulates from the CO2 source and keeps fluid from flowing into the CO2 Source.
The Endoscopic Clean Connecting Tubes and CO2 Source Tubing are provided sterile. The both device is sterilized by EO and the shelf life is three (3) years.
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K Number
K221331Device Name
Disposable Endoscope Valves System
Manufacturer
Date Cleared
2022-09-08
(126 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Changzhou Endoclean Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Endoscope Valves System includes an air/water valve, a biopsy valve, a biopsy valve and a water connector.
Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure.
Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water.
Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction.
Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.
Device Description
The Endoscope Valves System are used to fit to multiple endoscopes working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
It includes an air/water valve, a suction valve, a biopsy valve and a water connector. All valves are single-use device and packed individually in a sealed package or different types of valves products is packed into one package units. The valves are manufactured for use with OLYMPUS Endoscope Series, FUJIFILM Endoscope 700 Series, and Pentax 90 series endoscope. Some valve mav be sold as both sterile and non-sterile.
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