FDA applicant
Rfsu
FDA records 5 decisions for Rfsu (Stockholm, SE) from 1989 to 1990: 5 510(k) clearances. All are in product code HIS (Condom). 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 Rfsu’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Rfsu since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Rfsu’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