QGM

Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

Product code: QGM
Device name: Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
Device class: Class 2
21 CFR: 21 CFR 878.4405
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 3

FDA classification definition

This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Last three years. Most recent: 2024-10-30.

Number	Decision date	Applicant	Device name	Summary
K241902	2024-10-30	HistoSonics, Inc.	Edison System	FDA
K233466	2024-03-13	HistoSonics, Inc.	Edison System	PDF
DEN220087	2023-10-06	HistoSonics, Inc.	Edison System	—

1 summaries are archived here for direct download.

Official FDA classification page: QGM

Classification and pathway per current FDA publications. Data from openFDA (CC0).