# K233645: StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation -
- Decided: Dec 12, 2023 after 28 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 26 ancestors in all.
3 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)
- 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, Boston Scientific Corporation (2023) Summary page 6.

## Most influential descendants
- 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

## Recalls of this device
- Jul 22, 2026 · Class II · Z-3188-2026: A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing

## Indications for use
The LithoVue Elite Digital Flexible Ureteroscope System is intended to by 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/K233645
Methodology: https://510kreport.com/methodology