Senorx, Inc. · Class II · Cleared Oct 27, 2023
| K-number | K233220 |
| Device name | 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, ECPMR0110GBT) |
| Applicant | Senorx, Inc. |
| Product code | KNW |
| Device class | Class II |
| Decision date | Oct 27, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 876.1075 |
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