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Ultrasonic Urinary Stone Propulsion Device

FDA product code QNA · 1 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.4690
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-07-29 – 2026-07-29

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.

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