Product code SEW

Device name

Automated Endoscope Channel Cleaner

Medical specialty

General Hospital

Device class

2

Regulation number

880.6994

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset