FDA applicant
Fci (France Chirurgie Instrumentation) Sas
FDA records 8 decisions for Fci (France Chirurgie Instrumentation) Sas (Paris, FR) from 2012 to 2022: 8 510(k) clearances. Most are in product codes OKS (Lacrimal Stents And Intubation Sets) and HPZ (Implant, Eye Sphere). Its devices cite 12 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Fci Sas (France Chirurgie Instrumentation)”, “Fci (France Chirurgie Instrumentation)”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fci (France Chirurgie Instrumentation) Sas’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Fci (France Chirurgie Instrumentation)…’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