510(k) K141833 ยท HAW Neurological Stereotaxic Instrument
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Mar 25, 2015 |
| Received | Jul 7, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141833
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2023 | Medtronic Navigation, Inc. AxiEM" Non-Invasive Patient Tracker Open, Classified |
HAW | None listed |
| Jan 11, 2017 | Medtronic Navigation, Inc. AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton. Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.