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FDA PRODUCT CODE · CLASS II

QGM — Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

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

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4405
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K241902HistoSonics, Inc. · 510k2024-10-30

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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