HistoSonics, Inc.

FDA Regulatory Profile

HistoSonics, Inc. appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 29, 2026.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252947HistoSonics® Planning ToolMay 29, 2026
K241902Edison SystemOctober 30, 2024
K233466Edison SystemMarch 13, 2024
DEN220087Edison SystemOctober 6, 2023