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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 K240203
Device Name URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)
Applicant
Dyne Medical Group, Inc.
#1001-1011, 10f, 165, Gimpohangang 10-Ro 133beon-Gil
Gimpo-Si
Gyeonggi-Do,  KR 10071
Applicant Contact Moon Young-Hoon
Correspondent
Gms Consulting
#B-612, 66 Chengcho-Ro
Gyeonggi-Do,  KR 10543
Correspondent Contact Kim Jong-Hyun
Regulation Number876.1500
Classification Product Code
FGB  
Date Received01/25/2024
Decision Date 09/05/2024
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
Predetermined Change
Control Plan Authorized		 No
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