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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K232920
Device Name RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
Applicant
Ureteral Stent Company
45 Glenridge Ct.
Chagrin Falls,  OH  44022
Applicant Contact Mike Bunker
Correspondent
Ureteral Stent Company
45 Glenridge Ct.
Chagrin Falls,  OH  44022
Correspondent Contact Mike Bunker
Regulation Number876.4620
Classification Product Code
FAD  
Date Received09/19/2023
Decision Date 03/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT03266770
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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