510(k) K252913 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Break Wave
| Applicant | Sonomotion, Inc., San Mateo CA, US |
| Decision | Substantially Equivalent, Jan 12, 2026 |
| Received | Sep 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252913
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.