DeviceClearance

Product code SEW— General Hospital

CORIS System

Classification name
Automated Endoscope Channel Cleaner
Device class
Class 2
Regulation
21 CFR 880.6994
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SEW under 21 CFR 880.6994, via openFDA

Market context for product code SEW

FDA has cleared 2 devices under product code SEW between 2025 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SEW

Recent clearances under product code SEW

Data sourced from openFDA. This site is unofficial and independent of the FDA.