DEN230082 is an FDA 510(k) submission for the Stone Clear (SC-LP9-01). This device is classified as a Ultrasonic Urinary Stone Propulsion Device (Class II - Special Controls, product code QNA).
Submitted by Sonomotion, Inc. (San Mateo, US). The FDA issued a Not Cleared (DENG) decision on October 30, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4690. 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) Number | DEN230082 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 07, 2023 |
| Decision Date | October 30, 2024 |
| Days to Decision | 328 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | QNA - Ultrasonic Urinary Stone Propulsion Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4690 |
| 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. |