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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Endoscope Channel Cleaner
510(k) Number K253267
Device Name CORIS System
Applicant
Nanosonics Limited
7-11 Talavera Rd.
Macquarie Park,  AU 2113
Applicant Contact Nancy Kaiser
Correspondent
Nanosonics Limited
7-11 Talavera Rd.
Macquarie Park,  AU 2113
Correspondent Contact Nancy Kaiser
Classification Product Code
SEW  
Date Received09/29/2025
Decision Date 03/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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