510(k) K233220 · KNW Instrument, Biopsy
EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Driver (DRENCORMR); EnCor Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GB
| Applicant | Senorx, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Oct 27, 2023 |
| Received | Sep 28, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233220
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.