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510(k) Data Aggregation
K Number
K241168Device Name
System 83 Revolve Endoscope Washer/Disinfector
Manufacturer
Wassenburg Medical, Inc.
Date Cleared
2024-12-19
(237 days)
Product Code
FEB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Wassenburg Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The System 83 Revolve® Endoscope Washer/Disinfector is designed for the high-level disinfection of one or two flexible submersible endoscopes that are used in the gastrointestinal and pulmonary tracts. Flexible endoscopes that undergo bedside cleaning, are manually cleaned, and then exposed to the wash/disinfect cycle of the System 83 Revolve® may be high-level disinfected when the validated disinfection cycle of the System 83 Revolve® corresponds with the labeled contact conditions of the high-level disinfectant.
Device Description
The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical.
The System 83 Revolve® utilizes a processing chamber and the perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® 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 rhannels 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 flow, and the operating states of the components within System 83 Revolve". The system contains a Touchscreen (Graphical User Interface), a Barcode Scanner, an LED Indicator Strip that displays the process status, and a reprocessing chamber lid operation that is hands free.
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