510(k) K153660 ยท HAW Neurological Stereotaxic Instrument
StealthStation System with Cranial Software
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Sep 14, 2016 |
| Received | Dec 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2023 | Medtronic Navigation, Inc. StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems 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 |
| Dec 29, 2018 | Medtronic Navigation, Inc. StealthStation Cranial and Synergy Cranial Depth Gauge:
StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3. Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.