QNA — Ultrasonic Urinary Stone Propulsion Device Class II
Classification Details
- Product Code
- QNA
- Device Class
- Class II
- Regulation Number
- 876.4690
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230082 | sonomotion | Stone Clear (SC-LP9-01) | October 30, 2024 |