510(k) K210752 ยท NEU Marker, Radiographic, Implantable
HydroMARK Breast Biopsy Site Marker
| Applicant | Devicor Medical Products, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Apr 14, 2021 |
| Received | Mar 15, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210752
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2022 | Devicor Medical Products Inc HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 Terminated |
NEU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.