FDA Product Code OTZ: Graft Insertion Instrument For Endothelial Keratoplasty
A Graft Insertion Device For Endothelial Keratoplasty Is A Device Intended To Be Inserted Into The Eye During Surgery To Direct The Insertion Of A Corneal Graft And Be Removed After Insertion Is Completed.
Leading manufacturers include Corneagen, Inc..
5
Total
5
Cleared
424d
Avg days
2011
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Graft Insertion Instrument For Endothelial Keratoplasty Devices (Product Code OTZ)
5 devices
About Product Code OTZ - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code OTZ since 2011, with 5 receiving FDA clearance (average review time: 424 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
OTZ devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →