Product code QNA
- Device name
- Ultrasonic Urinary Stone Propulsion Device
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4690
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN230082 | Stone Clear (SC-LP9-01) | Sonomotion, Inc. | 2024-10-30 |