QGM — Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation Class II
FDA product code QGM covers "Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation", a Class II medical device regulated under 21 CFR 878.4405. Submissions are reviewed by the General, Plastic Surgery panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QGM
- Device Class
- Class II
- Regulation Number
- 878.4405
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.