FDA Product Code FFX: System, Gastrointestinal Motility (electrical)
Leading manufacturers include Covidien, LLC, Laborie Medical Technologies, Corp. and Medspira, LLC.
FDA 510(k) Cleared System, Gastrointestinal Motility (electrical) Devices (Product Code FFX)
About Product Code FFX - Regulatory Context
510(k) Submission Activity
69 total 510(k) submissions under product code FFX since 1976, with 69 receiving FDA clearance (average review time: 179 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under FFX have taken an average of 109 days to reach a decision - down from 180 days historically, suggesting improved FDA processing for this classification.
FFX devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →