510(k) K160797 ยท OTJ Laparoscopic Single Port Access Device
FMX314 Surgical Platform
| Applicant | Fortimedix Surgical B.V., Nuth, NL |
| Decision | Substantially Equivalent, Aug 26, 2016 |
| Received | Mar 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160797
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.