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510(k) Data Aggregation

    K Number
    K220395
    Device Name
    EndoGator Endoscopy Irrigation Tubing
    Manufacturer
    STERIS Corporation
    Date Cleared
    2022-03-11

    (28 days)

    Product Code
    FEQ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoGator Endoscopy Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).
    Device Description
    The ENDOGATOR Endoscopy Irrigation Tubing is composed of the following: 1) EndoGator™ Irrigation Tubing, and 2) EndoGator™ Irrigation Accessories. The ENDOGATOR Endoscopy Irrigation Tubing is indicated for irrigation during endoscopic procedures by using it in conjunction with an irrigation pump or cautery units, irrigation accessory, endoscope and disposable sterile water bottle. All tubing sets contain a back flow valve at the distal tip that allows irrigation water to travel in one direction, and therefore the risk of cross contamination is significantly reduced. The irrigation tubing sets are for twenty-four hour use and are to be discarded daily. The accessories are single-use devices and are to be discarded between patients. Tubing sets do not come into direct contact with patient tissue.
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    K Number
    K191559
    Device Name
    AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
    Manufacturer
    United States Endoscopy Group, Inc
    Date Cleared
    2019-08-01

    (49 days)

    Product Code
    FEQ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.
    Device Description
    Not Found
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    K Number
    K182258
    Device Name
    AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2018-09-21

    (31 days)

    Product Code
    FEQ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available water bottles.
    Device Description
    Not Found
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    K Number
    K173650
    Device Name
    AquaShield System CO2- Fujifilm
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2018-01-05

    (38 days)

    Product Code
    FEQ, FEO
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.
    Device Description
    Not Found
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    K Number
    K163424
    Device Name
    AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON
    Manufacturer
    United State Endoscopy Group, Inc.
    Date Cleared
    2017-01-04

    (29 days)

    Product Code
    FEQ, FEO
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.
    Device Description
    Not Found
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    K Number
    K162152
    Device Name
    Erbe’s CO2 Tubing/Cap Sets
    Manufacturer
    Erbe USA, Inc.
    Date Cleared
    2016-08-31

    (29 days)

    Product Code
    FEQ, FEO
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Erbe's CO2 Tubing/Cap Sets provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.
    Device Description
    In general; Erbe's CO2 Tubing/Cap Sets will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, nitrile rubber, acrylic, nylon, ink, solvent, adhesive, etc. The ERBEFLO CleverCap® CO2 devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air or CO2 for insufflation; whereas, the ERBEFLO AeroRinse® CO2 devices provide a conduit for water for endoscopic lens cleaning as well as air or CO2 for insufflation. There are three (3) types of Erbe's CO2 Tubing/Cap Sets for each group (i.e., ERBEFLO CleverCap® CO2and ERBEFLO AeroRinse® CO-) which each respectively interfaces with a specified brand of scope (i.e., Pentax, Olymous, and Fujinon Gastrointestinal video Endoscopes). There are two subsets of Sets for the Olympus scope in aech group; one that attaches to standard CO2 sources and the other which specifically attaches to an Olympus CO2 Unit Model UCR. The Sets consist of multiple tubing segments and a cap. The cap of a Set attaches with an air tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle cap, irrigation tubing of a Set (as applicable- only for the ERBEFLO CleverCap® CO2 Sets) interfaces with a designated pump and via ERBEFLO 2 single use connector accessories to the specified endoscope for endoscopic lavage. The next segment, the air/water tubing (also coming from the same water bottle cap), connects to an air/water port of a specified scope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube within a tube in which the endoscope's processor or CO2 Source (if used) is used to pressurize the bottle for functionality (air and water to the endoscope). Also, for the Pentax Set there is an additional air inlet tube that directs air for endoscope functional use. Or if CO2 is used, pressurization (air and water function) occurs via a CQ2 Source through the Set's CO2 segment.]. The third and final segment for both the Olympus and Fujinon Sets is for connecting to a CO2 Source for CO2 insufflation. For each Set, both the irrigation (as applicable) as well as the air/water tubing segments has a backflow valve. The CO2 segment of the Sets have a standard female luer connector for access a CO₂ Source or in the case of specified Olympus Sets there is a connector on the CO2 segment designed to accessing the Olympus CO3 Unit Model UCR. All of the CO2 segments have a hydrophobic air/gas filter which filters particulates from the CO, Source and keeps fluid from flowing into the CO2 Source. The irrigation (as applicable), air/water, and CO2 segments of the Sets have a clamp to close off the tubing while not in use. Additionally, each Set has an air/water connector(s) for its specified endoscope. Erbe's CO2 Tubing/Cap Sets are provided sterile and are disposable.
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    K Number
    K161482
    Device Name
    EndoChoice Water Bottle Cap Irrigation System
    Manufacturer
    ENDOCHOICE, INC.
    Date Cleared
    2016-06-27

    (27 days)

    Product Code
    FEQ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The water bottle cap irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
    Device Description
    The EndoChoice Water Bottle Cap Irrigation System is a sterile, consumable, 24-hour multi-patient use device designed to fit commercially available sterile water bottles and irrigation pumps for providing sterile water during endoscopic procedures. The EndoChoice water bottle cap system is comprised of a polycarbonate standard water bottle cap, medical grade PVC tubing that extends from the endoscope connector into the water bottle, and a medical grade stainless steel cylinder that serves as both the water intake portion of the disposable water bottle cap and a weight to hold the tubing down while in the water bottle. The bottle tubing is added into the sterile water bottle and the irrigation system is fastened via the tubing system cap. Flexible pump tubing connected to the top of the water bottle cap runs to the tubing connector reducer. This flexible tubing is the part of the device that is placed into the irrigation pump. A tubing connector reducer joins the flexible tubing and rigid tubing. The rigid tubing runs to the tubing Luer connector. The tubing Luer connector has the first one-way check valve which prevents potential backflow of fluid from the endoscope into the tubing set. The separately packaged, single-use endoscope connectors (used to connect the tubing set to the auxiliary water channel) also contain one-way valves used to prevent potential backflow. As with the predicate, the separately packaged, single-use connectors are used to connect to different endoscope models, and all include the second one-way valve to prevent contamination due to potential backflow. Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination. EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles of approximately 33 mm diameter. The water bottle cap system is supplied sterile and can be used up to 24 hours.
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    K Number
    K153588
    Device Name
    EndoChoice Water Bottle Cap System
    Manufacturer
    ENDOCHOICE, INC.
    Date Cleared
    2016-02-24

    (70 days)

    Product Code
    FEQ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.
    Device Description
    The EndoChoice water bottle cap system is a sterile disposable device designed to fit commercially available sterile water bottles for providing sterile water during endoscopic procedures. The water bottle cap system is designed with a clip that is placed on the tubing to stop water flow from the water bottle when the endoscope is not in use. The device attaches via a connector to the air/water port of an endoscope. The water bottle cap itself is attached to a standard sterile water bottle. Air supplied from the processor unit then pressurizes the water bottle, providing water flow when then air/water valve of the endoscope is depressed. Some models provide a feature that provides an option to use a CO2 air source. Instructions state that the device is to be used by trained endoscopy professionals.
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    K Number
    K153362
    Device Name
    AquaShield system CO2, AquaShield system-PENTAX
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    2015-12-16

    (26 days)

    Product Code
    FEQ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.
    Device Description
    Not Found
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    K Number
    K142155
    Device Name
    ENDOCHOICE WATER BOTTLE CAP SYSTEM
    Manufacturer
    ENDOCHOICE, INC.
    Date Cleared
    2015-01-20

    (167 days)

    Product Code
    FEQ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.
    Device Description
    The EndoChoice water bottle cap system is a sterile disposable device designed to fit commercially available sterile water bottles for providing sterile water during endoscopic procedures. The water bottle cap system is designed with a clip that is placed on the tubing to stop water flow from the water bottle when the endoscope is not in use. The device attaches via a connector to the air/water port of an endoscope. The water bottle cap itself is attached to a standard sterile water bottle. Air supplied from the processor unit then pressurizes the water bottle, providing water flow when then air/water valve of the endoscope is depressed. Some models provide a feature that provides an option to use a CO2 air source. Instructions state that the device is to be used by trained endoscopy professionals.
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