510(k) K222643 ยท PBY Temporary Tissue Marker
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
| Applicant | Sirius Medical Systems B.V., Eindhoven, NL |
| Decision | Substantially Equivalent, Oct 19, 2022 |
| Received | Sep 1, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K222643
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.