FDA Product Code
FDA Product Code QGM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4405
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241902 | Edison System | HistoSonics, Inc. | 2024-10-30 | Traditional | PDF ↗ |
| K233466 | Edison System | HistoSonics, Inc. | 2024-03-13 | Traditional | PDF ↗ |
| DEN220087 | Edison System | HistoSonics, Inc. | 2023-10-06 | Direct | — |
Product code QGM · Class II · General, Plastic Surgery. Data: openFDA.