FDA applicant
Distalmotion SA
FDA records 5 decisions for Distalmotion SA (Epalinges, CH) from 2024 to 2026: 4 510(k) clearances and 1 De Novo grant. All are in product code SDD (Electromechanical Surgical System Wherein The…). Its devices cite 4 predicates, 4 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 Distalmotion SA’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Distalmotion SA’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