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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K261400
Device Name Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large
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
FDS  
Subsequent Product Code
FAM  
Date Received04/29/2026
Decision Date 09/16/2026
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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