Panels › Obstetrics/Gynecology › Product code PMU · Class 2
Containment System, Laparoscopic Power Morcellation, With Instrument Port
Regulation 884.4050
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PMU
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Surgical Concepts | 2 | 0 |
| Agency For Medical Innovations GmbH | 1 | 0 |
| Ark Surgical | 1 | 0 |
| Olympus Corporation of the Americas | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 15, 2025 | K250212 | LapBox Power Tissue Containment System Ark Surgical, IL | PMU |
| Nov 10, 2021 | K212659 | More-Cell-System Agency For Medical Innovations GmbH, AT | PMU |
| Feb 25, 2020 | K192898 | PneumoLiner Advanced Surgical Concepts, IE | PMU |
| Apr 7, 2016 | DEN150028 | PneumoLiner Advanced Surgical Concepts, Ltd., IE | PMU |
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