Cleared Traditional

CORIS System

K253267 · Nanosonics Limited · General Hospital
Mar 2026
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K253267 is an FDA 510(k) clearance for the CORIS System, a Automated Endoscope Channel Cleaner (Class II — Special Controls, product code SEW), submitted by Nanosonics Limited (Macquarie Park, AU). The FDA issued a Cleared decision on March 5, 2026, 157 days after receiving the submission on September 29, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6994.

Submission Details

510(k) Number K253267 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date March 05, 2026
Days to Decision 157 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code SEW — Automated Endoscope Channel Cleaner
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6994
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.