510(k) K243945 ยท KNW Instrument, Biopsy
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
| Applicant | SurGenTec, LLC, Boca Raton FL, US |
| Decision | Substantially Equivalent, Apr 24, 2025 |
| Received | Dec 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243945
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.