StealthStation S8 System Platforms and StealthStation Cranial Software— 510(k) K162309

Substantially Equivalent

Medtronic 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..

Clearance details

Applicant: Medtronic Navigation, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2016-08-17
Decision date: 2017-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.