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2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Automated Endoscope Channel Cleaner

Device class

Class II (moderate risk)

Regulation

21 CFR 880.6994

Medical specialty

General Hospital

FDA definition

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.

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