510(k) K162309 ยท HAW Neurological Stereotaxic Instrument
StealthStation S8 System Platforms and StealthStation Cranial Software
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Mar 31, 2017 |
| Received | Aug 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162309
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2024 | Medtronic Navigation, Inc. Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or
percutaneous neurosurgical pr Open, Classified |
HAW | None listed |
| May 18, 2020 | Medtronic Navigation, Inc. Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imagin Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.