Edison System
FDA 510(k) clearance K241902 · decided 2024-10-30
Clearance details
- K-number
- K241902
- Device name
- Edison System
- Applicant
- HistoSonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-01
- Decision date
- 2024-10-30
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- QGM
- Device class
- 2
- Regulation number
- 878.4405
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Edison System (K233466) | HistoSonics, Inc. | 2024-03-13 |
| Edison System (DEN220087) | HistoSonics, Inc. | 2023-10-06 |
Recalls involving this device
No recalls on record reference this clearance.