# K201098: Ambu Duodeno System

- Pathway: 510(k) (Traditional)
- Applicant: Ambu Innovation GmbH
- Decided: Jul 17, 2020 after 84 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: 8 generations back to K931154 (1993). 30 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143153: Evis Exera II Duodenovideoscope Olympus TJF Type Q180V, Olympus Medical Systems Corp. (2016) Summary page 4.
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 4.

## Most influential descendants
- K233886: Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 (2024), 1 descendant of its own
- 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 is designed to be used with the aBox Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. video monitor) for endoscopy and endoscopic surgery within the duodenum. The aBox Duodeno is designed to be used with the aScope Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. medical grade video monitor) for endoscopy and endoscopic surgery within the duodenum

Source page: https://510kreport.com/device/K201098
Methodology: https://510kreport.com/methodology