Automated Endoscope Channel Cleaner
General Hospital · 21 CFR 880.6994
An automated endoscope channel cleaner is a device intended to replace all or a portion of manual cleaning of internal passages and ports of compatible reusable flexible endoscopes. Cleaning is conducted using an agent that exerts physical force (e.g., friction) on single or multiple channels of compatible endoscopes for removal of soil. This device type is not intended to provide or replace high-level disinfection or sterilization.
Recent MDR events
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510(k) clearances
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