510(k) K253761 · NEU Marker, Radiographic, Implantable
HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
| Applicant | Devicor Medical Products, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jan 23, 2026 |
| Received | Nov 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253761
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.