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510(k) DEN220087

Edison System by HistoSonics, Inc. — Product Code QGM

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: October 6, 2023
Date Received: December 2, 2022
Clearance Type: Direct
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.