510(k) K213818 ยท GCJ Laparoscope, General & Plastic Surgery
VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
| Applicant | Covidien, North Haven CT, US |
| Decision | Substantially Equivalent, Jun 27, 2022 |
| Received | Dec 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213818
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.