FDA Product Code ORE:
Leading manufacturers include Oystershell NV.
1
Total
1
Cleared
266d
Avg days
2024
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared ORE Devices (Product Code ORE)
1 devices
About Product Code ORE - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code ORE since 2024, with 1 receiving FDA clearance (average review time: 266 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
ORE devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →