STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
FDA 510(k) clearance K141833 · decided 2015-03-25
Clearance details
- K-number
- K141833
- Device name
- STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
- Applicant
- Medtronic Navigation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-07
- Decision date
- 2015-03-25
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AxiEM" Non-Invasive Patient Tracker recall (Z-1039-2023) | Medtronic Navigation, Inc. | 2023-01-30 |
| AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed recall (Z-1007-2017) | Medtronic Navigation, Inc. | 2017-01-11 |