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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 K250269
Device Name Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Martina Krautwald
Correspondent
Ambu, Inc.
6721 Columbia Gateway Dr., Suite 200
Columbia,  MD  21046
Correspondent Contact Sanjay Parikh
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received01/30/2025
Decision Date 06/11/2025
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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