510(k) K192898 ยท PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
PneumoLiner
| Applicant | Advanced Surgical Concepts, Bray, IE |
| Decision | Substantially Equivalent, Feb 25, 2020 |
| Received | Oct 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192898
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.