FDA Product Code FQH: Lavage, Jet
Leading manufacturers include Becton, Dickinson and Company, Smith & Nephew Medical Limited and Erbe Elektromedizin GmbH.
FDA 510(k) Cleared Lavage, Jet Devices (Product Code FQH)
About Product Code FQH - Regulatory Context
510(k) Submission Activity
53 total 510(k) submissions under product code FQH since 1979, with 53 receiving FDA clearance (average review time: 144 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 6 in the prior period.
FDA Review Time
Recent submissions under FQH have taken an average of 108 days to reach a decision - down from 145 days historically, suggesting improved FDA processing for this classification.
FQH devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →