Ultrasonic Urinary Stone Propulsion Device
The Ultrasonic Urinary Stone Propulsion Device is a urological device that visualizes urinary stones in the upper urinary tract and delivers focused acoustic pulses to reposition the stones, facilitating their natural passage through the urinary system. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 876.4690 in the Gastroenterology and Urology specialty. It carries product code QNA and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QNA
- Device Class
- FDA class 2
- Regulation Number
- 876.4690
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230082 | Stone Clear (SC-LP9-01) | Oct 30, 2024 | Unknown | Sonomotion, Inc. |