510(k) K201805 ยท GCJ Laparoscope, General & Plastic Surgery
VersaOne Reusable Positioning Trocar System
| Applicant | Covidien, North Haven CT, US |
| Decision | Substantially Equivalent, Aug 26, 2020 |
| Received | Jul 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201805
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2023 | Covidien LP VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS Open, Classified |
GCJ | None listed |
| Apr 26, 2023 | Covidien LP VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS Open, Classified |
GCJ | None listed |
| Apr 26, 2023 | Covidien LP VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS Open, Classified |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.