# K233275: RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Mar 25, 2024 after 178 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: 8 generations back to K931154 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153049: LithoVue System, Boston Scientific Corporation (2015) Summary page 5.

## Indications for use
The RenaFlexTM Single-use Flexible Ureteroscope is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. The Video System Center for Single Use Endoscopes is intended to provide illumination and receive, process, and output images from the compatible Olympus endoscope for diagnostics, treatment, and observation.

Source page: https://510kreport.com/device/K233275
Methodology: https://510kreport.com/methodology