510(k) K252646 ยท FCG Biopsy Needle
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Oct 24, 2025 |
| Received | Aug 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252646
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.