# K240849: Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Oct 16, 2024 after 203 days
- Product code: FAJ (Cystoscope 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 K921244 (1992). 53 ancestors in all.
No later device cites it as a predicate yet.
3 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193095: Ambu aScope 4 Cysto, Ambu A/S (2020) Summary page 5.
- K230332: Ambu® aScope™ Colon; Ambu® aBox™ 2, Ambu A/S (2023) Summary page 5.

## Indications for use
aScope 5 Cysto HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments. The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

Source page: https://510kreport.com/device/K240849
Methodology: https://510kreport.com/methodology