FDA product code · General and plastic surgery
Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
3 FDA decisions since 2023. 510(k) reviews decided 2021–2025 took a median of 131 days (half between 126 and 136). No recall names this code. The most-cited predicate is DEN220087, named by 1 later device.
This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QGM at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · QGM
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QGM
Too few QGM 510(k)s in any year since 2007 to give a median.
Recalls per year · QGM
No recall names QGM since 2007.
Adverse event reports per year · QGM
43in 2025
MAUDE reports naming product code QGM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 43 |
| 2026 | 0 | — | 0 | — |
Planning a device in QGM? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report