# K261153: LithoVue Elite Digital Flexible Ureteroscope System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Aug 26, 2026 after 140 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: 10 generations back to K931154 (1993). 27 ancestors in all.
No later device cites it as a predicate yet.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233645: StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection, Boston Scientific Corporation - (2023) Summary page 5.

## Indications for use
The LithoVue Elite Digital Flexible Ureteroscope System 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 in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

Source page: https://510kreport.com/device/K261153
Methodology: https://510kreport.com/methodology