510(k) K260365 · KNW Instrument, Biopsy
Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assi
| Applicant | Devicor Medical Products, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Mar 4, 2026 |
| Received | Feb 4, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260365
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.