K261086
- 510(k) number
- K261086
- Device name
- Break Wave
- Applicant
- Sonomotion, Inc. CA · US
- Product code
- LNS — Lithotriptor, Extracorporeal Shock-Wave, Urological
- Decision date
- 2026-04-29
- Date received
- 2026-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261086.pdf
Official FDA record: K261086
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.