SEW — Automated Endoscope Channel Cleaner Class II
FDA product code SEW covers "Automated Endoscope Channel Cleaner", a Class II medical device regulated under 21 CFR 880.6994. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
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.