FDA applicant
E-Cath Co., Ltd.
FDA records 1 decision for E-Cath Co., Ltd. (Golden, CO) in 2010: 1 510(k) clearance. All are in product code FFX (System, Gastrointestinal Motility (Electrical)). Its devices cite 2 predicates, 0 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 E-Cath Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2010high 1 (2010) · low 0 (2011)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like E-Cath Co., Ltd.’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