# K232919: Ambu® aScope™ Gastro Large; Ambu® aBox™ 2

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Apr 5, 2024 after 199 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212382: Ambu® aScope™ Gastro, Ambu® aBox™2, Ambu A/S (2022) Summary page 5.

## Most influential descendants
- K261400: Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large (2026), 0 descendants of its own

## Indications for use
Ambu® aScope™ Gastro Large: The endoscope is a sterile, single-use, flexible gastroscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy. The endoscope is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment. The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

Source page: https://510kreport.com/device/K232919
Methodology: https://510kreport.com/methodology