SEW · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6994
Classification
FDA Product Code
SEW
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6994
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.