DEN220087 is an FDA 510(k) submission for the Edison System. This device is classified as a Focused Ultrasound System For Non-thermal, Mechanical Tissue Ablation (Class II - Special Controls, product code QGM).
Submitted by HistoSonics, Inc. (Plymouth, US). The FDA issued a Not Cleared (DENG) decision on October 6, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4405. This Device Uses Focused Ultrasound To Mechanically Ablate Soft Tissue. The Device Is Not Intended To Thermally Ablate Tissue..
| 510(k) Number | DEN220087 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 02, 2022 |
| Decision Date | October 06, 2023 |
| Days to Decision | 308 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | QGM - Focused Ultrasound System For Non-thermal, Mechanical Tissue Ablation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4405 |
| Definition | This Device Uses Focused Ultrasound To Mechanically Ablate Soft Tissue. The Device Is Not Intended To Thermally Ablate Tissue. |