SEW — Automated Endoscope Channel Cleaner Class II

FDA Device Classification

Classification Details

Product Code
SEW
Device Class
Class II
Regulation Number
880.6994
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253267nanosonics limitedCORIS SystemMarch 5, 2026
DEN240018nanosonics limitedCORIS SystemMarch 19, 2025