QGM · Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
General, Plastic Surgery · 21 CFR 878.4405 · Class 2
Overview
| Product Code | QGM |
|---|---|
| Device Name | Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation |
| Regulation | 21 CFR 878.4405 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
The Edison System is a focused ultrasound system for non-thermal, mechanical tissue ablation. It uses high amplitude, short-duration focused ultrasound pulses to induce acoustic cavitation (a 'bubble cloud') at a focal location to mechanically destroy soft tissue, resulting in a homogenous acellular lysate. It is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors.
Classification Rationale
Class II (special controls). The device is a focused ultrasound system for non-thermal, mechanical tissue ablation, classified under 21 CFR 878.4405.
Special Controls
In combination with the general controls of the FD&C Act, the focused ultrasound system for non-thermal, mechanical tissue ablation is subject to the following special controls:
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241902 | Edison System | HistoSonics, Inc. | Oct 30, 2024 | SESE |
| K233466 | Edison System | HistoSonics, Inc. | Mar 13, 2024 | SESE |
| DEN220087 | Edison System | HistoSonics, Inc. | Oct 6, 2023 | DENG |
Top Applicants
- HistoSonics, Inc. — 3 clearances
