QNA · Class II · 21 CFR 876.4690

FDA Product Code QNA: Ultrasonic Urinary Stone Propulsion Device

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.

Leading manufacturers include Sonomotion, Inc..

1
Total
0
Cleared
328d
Avg days
2024
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Ultrasonic Urinary Stone Propulsion Device Devices (Product Code QNA)

1 devices
1–1 of 1
Not Cleared Oct 30, 2024
Stone Clear (SC-LP9-01)
DEN230082
Sonomotion, Inc.
Gastroenterology & Urology · 328d

About Product Code QNA - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QNA since 2024, with 0 receiving FDA clearance (average review time: 328 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

QNA devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →