# K230332: Ambu® aScope™ Colon; Ambu® aBox™ 2

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Sep 15, 2023 after 220 days
- Product code: FDF (Colonoscope 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.
6 later devices descend from it; 4 cite it directly.
3 of 35 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
- K233630: Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2 (2024), 1 descendant of its own
- K233886: Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 (2024), 1 descendant of its own
- K261400: Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large (2026), 0 descendants 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
- K240849: Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K230332
Methodology: https://510kreport.com/methodology