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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 K242108
Device Name Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Gamze Yilan
Correspondent
Ambu, Inc.
6721 Columbia Gateway Dr.
Suite 200
Columbia,  MD  21046
Correspondent Contact Sanjay Parikh
Regulation Number876.1500
Classification Product Code
FGB  
Subsequent Product Codes
EOQ   FET  
Date Received07/18/2024
Decision Date 08/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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