FDA product code QGM: Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
QGM is the FDA product code for focused ultrasound system for non-thermal, mechanical tissue ablation. It is a Class II device, regulated under 21 CFR 878.4405 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under QGM, 2 in the last five years. The average 510(k) review took 131 days (median 131); 131 days on average over the last three years. 1 De Novo request was granted under it.
Definition
This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
Classification
| Field | Value |
|---|---|
| Device name | Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation |
| Device class | Class II |
| Regulation | 21 CFR 878.4405 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QGM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 2 | 131 |
Compare with all 510(k) review times · Search every QGM clearance
Top QGM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| HistoSonics, Inc. | 2 | 2024-10-30 |
Most recent QGM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241902 | HistoSonics, Inc. | Edison System | 2024-10-30 | 121 |
| K233466 | HistoSonics, Inc. | Edison System | 2024-03-13 | 141 |
Recalls for QGM devices
openFDA lists no recalls for product code QGM.
Frequently asked questions
What is FDA product code QGM?
QGM is the FDA product code for focused ultrasound system for non-thermal, mechanical tissue ablation. It is a Class II device, regulated under 21 CFR 878.4405 and reviewed by the General and Plastic Surgery panel.
What device class is QGM?
Class II, regulation 21 CFR 878.4405. Typical premarket route: 510(k).
How long does a 510(k) take for product code QGM?
Across 2 cleared submissions the average was 131 days from receipt to decision (median 131).
Which companies have the most QGM clearances?
HistoSonics, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QGM
- Run a recall and safety report across every QGM manufacturer
- Watch product code QGM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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