Edison System— 510(k) K241902
Substantially EquivalentHistoSonics, Inc.
FDA 510(k) clearance K241902 for Edison System, Substantially Equivalent on 2024-10-30. Applicant: HistoSonics, Inc..
Clearance details
- Applicant
- HistoSonics, Inc.
- Product code
- Code QGM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Adverse events under product code QGM
product code QGM- Death
- 9
- Total
- 9
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.