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510(k) Data Aggregation
K Number
K162120Device Name
Scope-Assist Flushing Sink
Manufacturer
Custom Ultrasonics Inc.
Date Cleared
2017-04-28
(270 days)
Product Code
FEB
Regulation Number
876.1500Why 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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