# K242108: Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance

- Pathway: 510(k) (Special)
- Applicant: Ambu A/S
- Decided: Aug 16, 2024 after 29 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: 13 generations back to K921244 (1992). 66 ancestors in all.
No later device cites it as a predicate yet.
3 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233630: Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2, Ambu A/S (2024) Summary page 5.
- K233671: Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance, Ambu A/S (2024) Summary page 5.

## Indications for use
Ambu® 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. Ambu® 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. Ambu® 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. Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.

Source page: https://510kreport.com/device/K242108
Methodology: https://510kreport.com/methodology