# K261400: Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Sep 16, 2026 after 140 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: 10 generations back to K931154 (1993). 38 ancestors in all.
No later device cites it as a predicate yet.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210162: Endoscope Model EI-740D/S, Fujifilm Corporation (2021) Summary page 5.
- K212382: Ambu® aScope™ Gastro, Ambu® aBox™2, Ambu A/S (2022) Summary page 5.
- K232919: Ambu® aScope™ Gastro Large; Ambu® aBox™ 2, Ambu A/S (2024) Summary page 5.
- K230332: Ambu® aScope™ Colon; Ambu® aBox™ 2, Ambu A/S (2023) Summary page 5.

## Indications for use
The device is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy. The endoscope is also intended to be used for endoscopic access to and examination of the lower gastrointestinal anatomy, specifically the rectum and the sigmoid colon. The endoscope is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.

Source page: https://510kreport.com/device/K261400
Methodology: https://510kreport.com/methodology