FDA applicant
Crospon, Ltd.
FDA records 12 decisions for Crospon, Ltd. (Bonita Springs, FL) from 2009 to 2019: 12 510(k) clearances. Most are in product codes FFX (System, Gastrointestinal Motility (Electrical)) and PIE (Esophageal Dilator With Balloon And Electrode…). Its devices cite 20 predicates, 11 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Crospon, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Crospon, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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