510(k) K230646 ยท KNW Instrument, Biopsy
SUREcore Prime Biopsy Instrument
| Applicant | Uro-1 Medical, Inc., Greensboro NC, US |
| Decision | Substantially Equivalent, Nov 29, 2023 |
| Received | Mar 8, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230646
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.