HistoSonics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
HistoSonics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: HistoSonics® Planning Tool, Edison System, Edison System
4
Total
3
Cleared
1
Denied
HistoSonics, Inc. has 3 FDA 510(k) cleared medical devices. Based in Plymouth, US.
Latest FDA clearance: May 2026. Active since 2023. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by HistoSonics, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - HistoSonics, Inc.
4 devices