FDA Product Code ORQ: Mesh, Surgical, Deployer
Intended To Be Used To Facilitate The Delivery Of Soft Tissue Prosthetics During The Laparoscopic Repair Of Soft Tissue Defects (e.g. Hernia Repair).
Leading manufacturers include Conmed Corporation.
6
Total
6
Cleared
28d
Avg days
2010
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
54d
recently vs 23d historically
FDA 510(k) Cleared Mesh, Surgical, Deployer Devices (Product Code ORQ)
6 devices
About Product Code ORQ - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code ORQ since 2010, with 6 receiving FDA clearance (average review time: 28 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.
FDA 510(k) Review Time - ORQ Product Code
Recent submissions under ORQ have taken an average of 54 days to reach a decision - up from 23 days historically. Manufacturers should account for longer review timelines in current project planning.
ORQ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →