510(k) K233466
K233466 is an FDA 510(k) premarket notification submitted by HistoSonics, Inc. for the device "Edison System". The FDA issued a decision of Substantially Equivalent on March 13, 2024. The device falls under product code QGM (Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation), a Class II device regulated under 21 CFR 878.4405. HistoSonics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2024
- Date Received
- October 24, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
- Device Class
- Class II
- Regulation Number
- 878.4405
- Review Panel
- SU
- Submission Type
This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.