# K233630: Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Jun 24, 2024 after 224 days
- Product code: FGB (Ureteroscope 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). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153049: LithoVue System, Boston Scientific Corporation (2015) Summary page 5.
- K230332: Ambu® aScope™ Colon; Ambu® aBox™ 2, Ambu A/S (2023) Summary page 5.

## Most influential descendants
- K242108: Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance (2024), 0 descendants of its own

## Indications for use
The aScope 5 Uretero is a sterile, single-use, flexible, digital video ureteroscope intended to be used for endoscopic access and visual guidance in the upper urinary tract. aScope 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel. aScope 5 Uretero is intended for patients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for visualization and examination with a flexible ureteroscope, and for removal of renal and ureter calculi. The aBox TM 2 is intended to display live imaging data from compatible Ambu visualization devices.

Source page: https://510kreport.com/device/K233630
Methodology: https://510kreport.com/methodology