FDA Product Code LYA: Splint, Intranasal Septal
Leading manufacturers include Spirair, Inc..
FDA 510(k) Cleared Splint, Intranasal Septal Devices (Product Code LYA)
About Product Code LYA - Regulatory Context
510(k) Submission Activity
46 total 510(k) submissions under product code LYA since 1983, with 46 receiving FDA clearance (average review time: 96 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 LYA have taken an average of 227 days to reach a decision - up from 93 days historically. Manufacturers should account for longer review timelines in current project planning.
LYA devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →