QNA

Ultrasonic Urinary Stone Propulsion Device

Product code
QNA
Device name
Ultrasonic Urinary Stone Propulsion Device
Device class
Class 2
21 CFR
21 CFR 876.4690
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification definition

An ultrasonic urinary stone propulsion device visualizes urinary stones in the upper urinary tract and delivers focused acoustic pulses to reposition the stones to facilitate their passage.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-07-29.

NumberDecision dateApplicantDevice nameSummary
K2622002026-07-29Sonomotion, Inc.Stone Clear (BWSC-LP9-02)PDF
DEN2300822024-10-30Sonomotion, Inc.Stone Clear (SC-LP9-01)

1 summaries are archived here for direct download.

Official FDA classification page: QNA
Classification and pathway per current FDA publications. Data from openFDA (CC0).