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
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.