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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device automated endoscope channel cleaner
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.
Product CodeSEW
Regulation Number 880.6994
Device Class 2


Premarket Reviews
ManufacturerDecision
NANOSONICS LIMITED
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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