# K223926: VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

- Pathway: 510(k) (Traditional)
- Applicant: Medimaging Integrated Solution, Inc (Miis)
- Decided: Oct 6, 2023 after 280 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). 44 ancestors in all.
No later device cites it as a predicate yet.
2 of 45 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 6.

## Indications for use
The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system (VersaVue™ Tablet OR VersaVue™ Video Box). The device provides endoscopic procedure and surgical treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.

Source page: https://510kreport.com/device/K223926
Methodology: https://510kreport.com/methodology