510(k) K223682 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, Nov 9, 2023 |
| Received | Dec 8, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223682
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.