FDA Product Code SEW: Automated Endoscope Channel Cleaner
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.
Leading manufacturers include Nanosonics Limited.
FDA 510(k) Cleared Automated Endoscope Channel Cleaner Devices (Product Code SEW)
About Product Code SEW - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SEW since 2025, with 1 receiving FDA clearance (average review time: 240 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SEW devices are reviewed by the General Hospital panel. Browse all General Hospital devices →