FDA Product Code KZH: Introducer, Syringe Needle
Leading manufacturers include Synthon Hispania S.L..
FDA 510(k) Cleared Introducer, Syringe Needle Devices (Product Code KZH)
About Product Code KZH - Regulatory Context
510(k) Submission Activity
47 total 510(k) submissions under product code KZH since 1979, with 47 receiving FDA clearance (average review time: 116 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under KZH have taken an average of 54 days to reach a decision - down from 117 days historically, suggesting improved FDA processing for this classification.
KZH devices are reviewed by the General Hospital panel. Browse all General Hospital devices →