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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K240848
Device Name Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Gurpreet Kaur Rehal
Correspondent
Ambu, Inc.
6721 Columbia Gateway Dr., Suite 200
Columbia,  MD  21046
Correspondent Contact Sanjay Parikh
Regulation Number876.1500
Classification Product Code
FAJ  
Subsequent Product Code
FET  
Date Received03/27/2024
Decision Date 10/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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