510(k) K212158 ยท NEU Marker, Radiographic, Implantable
HydroMARK Breast Biopsy Site Marker
| Applicant | Devicor Medical Products, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Apr 21, 2022 |
| Received | Jul 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212158
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2026 | Devicor Medical Products Inc HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 Open, Classified |
NEU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.