510(k) K233466
- Device
- Edison System
- Applicant
- HistoSonics, Inc.
- 510(k) number
- K233466
- Product code
- QGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-13
- Date received
- 2023-10-24
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Daniel Kosednar
- Address
- 16305 36th Ave. N. Suite 300 Plymouth MN US 55446 55446
FDA Registration Numbers#
- 3027664504