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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Germicide, Cleaning, For Endoscopes
510(k) Number K220361
Device Name Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
Applicant
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Jennifer Nalepka
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Jennifer Nalepka
Regulation Number876.1500
Classification Product Code
NZA  
Date Received02/08/2022
Decision Date 03/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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