510(k) DEN220087
- Device
- Edison System
- Applicant
- HistoSonics, Inc.
- 510(k) number
- DEN220087
- Product code
- QGM
- Decision
- Unknown (DENG)
- Decision date
- 2023-10-06
- Date received
- 2022-12-02
- Regulation
- 878.4405
- Classification name
- Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Daniel Kosednar
- Address
- 16305 36th Ave. N. Suite 300 Plymouth MN US 55446 55446
FDA Registration Numbers#
- 3027664504
Source Documents#
510(k) summary PDF not indicated by FDA