FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Edison System
K Number: DEN220087
·
Decision Oct 6, 2023
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
4
Review Days
308
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Basic Information
- Device Name
- Edison System
- K Number
- DEN220087
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 878.4405
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- HistoSonics, Inc.
- Date Received
- December 2, 2022
- Decision Date
- October 6, 2023
- Product Code
- QGM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QGM | Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QGM), ordered by most recent decision date.
Edison System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Edison System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery