FDA applicant
Fiagon GmbH
FDA records 16 decisions for Fiagon GmbH (Hennigsdorf, DE) from 2014 to 2026: 16 510(k) clearances. Most are in product codes PGW (Ear, Nose, And Throat Stereotaxic Instrument) and HAW (Neurological Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 79 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 29 predicates, 14 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fiagon GmbH’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Fiagon GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report