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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 K213444
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 Court
Chagrin Falls,  OH  44022
Applicant Contact Mike Bunker
Correspondent
Ureteral Stent Company
45 Glenridge Court
Chagrin Falls,  OH  44022
Correspondent Contact Mike Bunker
Regulation Number876.4620
Classification Product Code
FAD  
Date Received10/25/2021
Decision Date 03/17/2022
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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