510(k) K253856 ยท HAW Neurological Stereotaxic Instrument
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
| Applicant | Koh Young Technology, Inc., Yeoju, KR |
| Decision | Substantially Equivalent, Sep 10, 2026 |
| Received | Dec 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253856
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.