StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)— 510(k) K200723

Substantially Equivalent

Medtronic Navigation, Inc.

FDA 510(k) clearance K200723 for StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762), Substantially Equivalent on 2020-06-26. Applicant: Medtronic Navigation, Inc..

Clearance details

Applicant: Medtronic Navigation, Inc.
Product code: Code PGW
Advisory panel: Neurology
Date received: 2020-03-19
Decision date: 2020-06-26
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.