Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
The Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation uses focused ultrasound energy to mechanically ablate soft tissue without thermal effects, offering a non-invasive approach to tissue removal for surgical applications. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 878.4405 in the General and Plastic Surgery specialty. The product code is QGM. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QGM
- Device Class
- FDA class 2
- Regulation Number
- 878.4405
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.