510(k) Report

Devices descending from K212382

2 later devices reach Ambu® aScope™ Gastro, Ambu® aBox™2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+1K232919Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Ambu A/S20241—