StealthStation S8 System Platforms and StealthStation Cranial Software— 510(k) K162309
Substantially EquivalentMedtronic Navigation, Inc.
FDA 510(k) clearance K162309 for StealthStation S8 System Platforms and StealthStation Cranial Software, Substantially Equivalent on 2017-03-31. Applicant: Medtronic Navigation, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Navigation, Inc.
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, CO, US
Recent devices under product code HAW
view allMore clearances from Medtronic Navigation, Inc.
view allAdverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K162309
K-number listed on FDA's recall record- Z-1776-2024 — 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 procedures.
- Z-1995-2020 — 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 Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure. Neurological stereotaxic Instrument.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162309.
Data sourced from openFDA. This site is unofficial and independent of the FDA.