San Mateo, CA, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QNA | Ultrasonic Urinary Stone Propulsion Device | Class II | Gastroenterology, Urology | 2 | 2026-07-29 |
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | Class II | Gastroenterology, Urology | 2 | 2026-04-29 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-29 | K262200 | Stone Clear (BWSC-LP9-02) | QNA | Class II | Gastroenterology, Urology |
| 2026-04-29 | K261086 | Break Wave | LNS | Class II | Gastroenterology, Urology |
| 2026-01-12 | K252913 | Break Wave | LNS | Class II | Gastroenterology, Urology |
| 2024-10-30 | DEN230082 | Stone Clear (SC-LP9-01) | QNA | Class II | Gastroenterology, Urology |