Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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
    Ask a Question

    Page 1 of 1