FDA Product Code QGM: Focused Ultrasound System For Non-thermal, Mechanical Tissue Ablation
This Device Uses Focused Ultrasound To Mechanically Ablate Soft Tissue. The Device Is Not Intended To Thermally Ablate Tissue.
Leading manufacturers include HistoSonics, Inc..
FDA 510(k) Cleared Focused Ultrasound System For Non-thermal, Mechanical Tissue Ablation Devices (Product Code QGM)
About Product Code QGM - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QGM since 2023, with 2 receiving FDA clearance (average review time: 190 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under QGM have taken an average of 121 days to reach a decision - down from 225 days historically, suggesting improved FDA processing for this classification.
QGM devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →