# K233886: Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Apr 16, 2024 after 130 days
- Product code: FDT (Duodenoscope 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). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201098: Ambu Duodeno System, Ambu Innovation GmbH (2020) Summary page 5.
- K143153: Evis Exera II Duodenovideoscope Olympus TJF Type Q180V, Olympus Medical Systems Corp. (2016) Summary page 5.
- K230332: Ambu® aScope™ Colon; Ambu® aBox™ 2, Ambu A/S (2023) Summary page 5.

## Most influential descendants
- K251861: FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 (2026), 0 descendants of its own

## Indications for use
The aScope™ Duodeno 2 is designed to be used with the aBox™ 2, endoscopic accessories (e.g., biopsy forceps) and other ancillary equipment (e.g., medical grade video monitor) for endoscopy and endoscopic surgery within the duodenum. The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

Source page: https://510kreport.com/device/K233886
Methodology: https://510kreport.com/methodology