FDA applicant
Sanibel Supply
FDA records 1 decision for Sanibel Supply (Assens, DK) in 2011: 1 510(k) clearance. All are in product code GXY (Electrode, Cutaneous). 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 Sanibel Supply’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2011high 1 (2011) · low 0 (2012)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Sanibel Supply’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