# K193095: Ambu aScope 4 Cysto

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Apr 2, 2020 after 147 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: 9 generations back to K921244 (1992). 43 ancestors in all.
13 later devices descend from it; 10 cite it directly.
2 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160766: Ambu USR, Ambu M, Ambu A/S (2016) Summary page 4.

## Most influential descendants
- K222162: Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (2022), 1 descendant of its own
- K222602: Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) (2022), 1 descendant of its own
- K212202: WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System (2022), 1 descendant of its own
- K251140: Zenflow Spring Scope (2025), 0 descendants of its own
- K252598: Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (2025), 0 descendants of its own

## Indications for use
Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Ambu® aScope™ 4 Cysto is intended to provide visualization via Ambu® displaying unit and can be used with endoscopic accessories. Ambu® aScope™ 4 Cysto is intended for use in a hospital environment or medical office environment. Ambu® aScope™ 4 Cysto is designed for use in adults.

Source page: https://510kreport.com/device/K193095
Methodology: https://510kreport.com/methodology