# K221515: StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Feb 2, 2023 after 253 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.
4 later devices descend from it; 2 cite it directly.
1 of 30 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 4.

## Most influential descendants
- K233645: StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection (2023), 3 descendants of its own
- K241598: LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring)   (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring)  (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring)  (M0067941500) (2024), 1 descendant of its own
- K261153: LithoVue Elite Digital Flexible Ureteroscope System (2026), 0 descendants of its own
- K252703: LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) (2025), 0 descendants of its own

## 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/K221515
Methodology: https://510kreport.com/methodology