Break Wave— 510(k) K261086

Substantially Equivalent

Sonomotion, Inc.

FDA 510(k) clearance K261086 for Break Wave, Substantially Equivalent on 2026-04-29. Applicant: Sonomotion, Inc..

Clearance details

Applicant: Sonomotion, Inc.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2026-04-01
Decision date: 2026-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: San Mateo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNS

product code LNS

Death: 4
Injury: 320
Total: 324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.