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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2021 | Olympus Corporation of the Americas ASC PneumoLiner device, Part No. WA90500US (US market only)
The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologi Terminated |
PMU | K192898 |
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