FDA Product Code GEJ: Carrier, Ligature
Leading manufacturers include Cypris Medical.
5
Total
5
Cleared
48d
Avg days
1987
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Carrier, Ligature Devices (Product Code GEJ)
5 devices
About Product Code GEJ - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code GEJ since 1987, with 5 receiving FDA clearance (average review time: 48 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
GEJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →