510(k) K212397 ยท HAW Neurological Stereotaxic Instrument
StealthStation S8 Cranial v2.0
| Applicant | Medtronic Navigation, Louisville CO, US |
| Decision | Substantially Equivalent, Dec 22, 2021 |
| Received | Aug 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2023 | Medtronic Navigation, Inc. StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762)
The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either Open, Classified |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.