# K212382: Ambu® aScope™ Gastro, Ambu® aBox™2

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Feb 3, 2022 after 185 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: 8 generations back to K931154 (1993). 28 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 4.

## Most influential descendants
- K232919: Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 (2024), 1 descendant of its own
- K261400: Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large (2026), 0 descendants of its own

## Indications for use
The aScope Gastro is a sterile, single-use, flexible gastroscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy. The aScope Gastro is intended to provide visualization via a compatible Ambu displaying unit and to be used with endo-therapy 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/K212382
Methodology: https://510kreport.com/methodology