510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QGMClass II

Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

21 CFR 878.4405 / General, Plastic Surgery
FDA source (opens on fda.gov)

QGM is the FDA product code for Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation, a class II device type, regulated under 21 CFR 878.4405. FDA's definition for this code reads: "This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QGM
Device name
Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
FDA definition
This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
Regulation
21 CFR 878.4405
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QGM

By decision year
3 clearances under product code QGM with a decision year between 2023 and 2024, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QGM by decision year
YearClearances
20231
20242

Applicants with the most clearances

Product code QGM
Applicants holding the most 510(k) clearances under product code QGM
ApplicantClearances
Histosonics, Inc3

Companies listing this code with FDA

Companies whose registered establishments list this code