StealthStationTM S8 ENT Software— 510(k) K170018

Substantially Equivalent

Medtronic Navigation, Inc.

FDA 510(k) clearance K170018 for StealthStationTM S8 ENT Software, Substantially Equivalent on 2017-05-19. Applicant: Medtronic Navigation, Inc..

Clearance details

Applicant: Medtronic Navigation, Inc.
Product code: Code PGW
Advisory panel: Neurology
Date received: 2017-01-03
Decision date: 2017-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PGW

product code PGW

Malfunction: 1,199
Total: 1,199

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.