Ambu A/S - FDA 510(k) Cleared Devices

Cleared Jun 11, 2025

Ambu® aScope™ 5 Cysto HD (Standard Deflection)

K250269 · FAJ

Gastroenterology & Urology · 132d

Cleared Oct 16, 2024

Ambu® aScope™ 5 Cysto HD (Standard Deflection)

K240849 · FAJ

Gastroenterology & Urology · 203d

Cleared Oct 10, 2024

Ambu® aScope™ 5 Cysto HD (Standard Deflection)

K240848 · FAJ

Gastroenterology & Urology · 197d

Cleared Aug 16, 2024

Ambu® aScope™ 5 Uretero (Standard Deflection)

K242108 · FGB

Gastroenterology & Urology · 29d

Cleared Jun 24, 2024

Ambu® aScope™ 5 Uretero (Standard Deflection)

K233630 · FGB

Gastroenterology & Urology · 224d

Cleared Apr 16, 2024

Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2

K233886 · FDT

Gastroenterology & Urology · 130d

Cleared Apr 05, 2024

Ambu® aScope™ Gastro Large

K232919 · FDS

Gastroenterology & Urology · 199d

Cleared Sep 15, 2023

Ambu® aScope™ Colon

K230332 · FDF

Gastroenterology & Urology · 220d

Cleared Feb 03, 2022

Ambu® aScope™ Gastro, Ambu® aBox™2

K212382 · FDS

Gastroenterology & Urology · 185d

Cleared Apr 02, 2020

Ambu aScope 4 Cysto

K193095 · FAJ

Gastroenterology & Urology · 147d

Cleared Aug 17, 2016

Ambu USR, Ambu M

K160766 · FAJ

Gastroenterology & Urology · 149d