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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ureteroscope and accessories, flexible/rigid
510(k) Number K211347
Device Name Uretero1 Ureteroscope System
Applicant
STERIS Corporation
5976 Heisley Road
Mentor,  OH  44060
Applicant Contact Caroll Martin
Correspondent
STERIS Corporation
5976 Heisley Road
Mentor,  OH  44060
Correspondent Contact Caroll Martin
Regulation Number876.1500
Classification Product Code
FGB  
Date Received05/03/2021
Decision Date 11/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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