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510(k) Data Aggregation

    K Number
    K173590
    Device Name
    System 83 Plus Washer/Disinfector
    Manufacturer
    Custom Ultrasonics, Inc.
    Date Cleared
    2020-03-30

    (860 days)

    Product Code
    FEB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Custom Ultrasonics, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    System 83 Plus™ Washer/Disinfector is designed for the simultaneous high level disinfection of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible endoscopes that are precleaned and manually cleaned, and then exposed to the washing /disinfection cycle of the System 83 Plu s™, may be high level disinfected when the disinfection cycle corresponds to the System 83 Plus™ validated contact conditions of the high level disinfectant. Note: The System 83 Plus™ device includes two models. · The System 83 Plus™ 2 has one processing chamber that can process 1 to 2 flexible endoscopes at a time . · The System 83 Plus™ 9 has two processing chambers that can process 1 to 2 flexible endoscopes at a time in each independently operated processing chamber for a total of up to 4 endoscopes simultaneously.
    Device Description
    The System 83 Plus™ is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes (per bay) utilizing a detergent and FDA cleared high-level disinfectant validated by CUI. The System 83 Plus™ device family includes two models. The System 83 Plus™ 2; a model with one processing chamber, which can process one to two flexible endoscopes at a time. The System 83 Plus™ 9: a model with two processing chambers which can asynchronously reprocess up to 2 endoscopes per bay (total of up to 4 endoscopes). The System 83 Plus™ utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high level disinfected endoscope. The System 83 Plus™ is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocessing information with a printer. Built-in sensors detect fluid levels, fluid temperature, fluid flow, and the operating states of the components within System 83 Plus™.
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    K Number
    K162120
    Device Name
    Scope-Assist Flushing Sink
    Manufacturer
    Custom Ultrasonics Inc.
    Date Cleared
    2017-04-28

    (270 days)

    Product Code
    FEB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Custom Ultrasonics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scope-Assist Flushing Sink is indicated for flushing the channels of flexible endoscopes according to the endoscope manufacturer's instructions.
    Device Description
    The Scope-Assist Flushing Sink is designed to mechanically assist the channel flushing portion of an endoscope's manual cleaning process. The sink facilitates compliance with endoscope manufacturer's cleaning requirements by: • Providing a means of flushing flexible endoscope channels with detergent solution • Providing a means of flushing endoscope channels with water • Providing an environment for soaking and manual wiping/brushing of flexible endoscope exterior surfaces and accessories • Providing an environment to perform wet leak testing of endoscopes The Scope-Assist Flushing Sink is designed: • To be used where the facility performs its endoscope cleaning functions, such as in soiled utility rooms, central processing decontamination areas, or endoscope cleaning (reprocessing) areas. • To be used with Tergal 800 Detergent The Scope-Assist Flushing Sink is not designed: ● To be used at bedside, in critical care units, or in sterile environments ● To be used as a terminal process or as part of the manual high level disinfection process
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    K Number
    K122172
    Device Name
    SYSTEM 83 PLUS
    Manufacturer
    CUSTOM ULTRASONICS
    Date Cleared
    2013-01-25

    (186 days)

    Product Code
    FEB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUSTOM ULTRASONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    System 83 Plus Endoscope Washer/Disinfector is designed for the simultaneous reprocessing of up to two flexible submentible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible scopes that are submention oneoooped to the washing/disinfection cycle of the System 83 Plus may be high level disinfected predicalled and the ruspood to the labeled contact conditions for the germicide as in the predicated device. Note: System 83 Plus device includes two models. Note. System 83 Plus 2 is a device with one processing chamber which can process 1 to 2 flexible endoscopes at a time. The System 83 Plus 9 is two 'System 83 Plus 2' units put together. It has two processing chambers which can process 1 to 2 flexible endoscopes in each independently operated processing chamber.
    Device Description
    System 83 Plus Endoscope Washer/Disinfector is designed for the simultaneous reprocessing of up to two flexible submentible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible scopes that are submention oneoooped to the washing/disinfection cycle of the System 83 Plus may be high level disinfected predicalled and the ruspood to the labeled contact conditions for the germicide as in the predicated device. Note: System 83 Plus device includes two models. Note. System 83 Plus 2 is a device with one processing chamber which can process 1 to 2 flexible endoscopes at a time. The System 83 Plus 9 is two 'System 83 Plus 2' units put together. It has two processing chambers which can process 1 to 2 flexible endoscopes in each independently operated processing chamber.
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    K Number
    K061430
    Device Name
    SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
    Manufacturer
    CUSTOM ULTRASONICS
    Date Cleared
    2007-01-12

    (234 days)

    Product Code
    FEB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUSTOM ULTRASONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MinFlex Washer-Disinfector is intended for washing and high-level disinfecting one or two submersible flexible endoscopes that do not contact normally sterile areas of the body and that feature either no internal channel (i.e., a probe) or one internal channel. The types of flexible endoscopes for which the MinFlex Washer-Disinfector is labeled include those that are used to examine, diagnose, and treat diseases of the pulmonary tract, urinary tract, uterine cavity, and ear, nose, and throat (ENT) cavities.
    Device Description
    System 83 Plus MiniFlex Washer -- Disinfector
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    K Number
    K983017
    Device Name
    MODIFICATION TO SYSTEM 83 PLUS
    Manufacturer
    CUSTOM ULTRASONICS
    Date Cleared
    1998-09-22

    (25 days)

    Product Code
    NVE, KOG
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUSTOM ULTRASONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The System 83 Plus Endoscope Washer/Disinfector is designed for the simultaneous reprocessing of up to two flexible endoscopes used in the gastrointestinal and/or pulmonary tracts. These flexible scopes may be high level disinfected when the washing/disinfection cycle of the System 83 Plus is used with the labeled contact conditions for the germicide as in the predicated device.
    Device Description
    Not Found
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