FIAGON NAVIGATION SYSTEM— 510(k) K133573

Substantially Equivalent

Fiagon GmbH

FDA 510(k) clearance K133573 for FIAGON NAVIGATION SYSTEM, Substantially Equivalent on 2014-04-30. Applicant: Fiagon GmbH.

Clearance details

Applicant: Fiagon GmbH
Product code: Code PGW
Advisory panel: Neurology
Date received: 2013-11-20
Decision date: 2014-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hennigsdorf, DE

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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.