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 Covidien, LLC and 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
Cleared
Apr 07, 2025
BioBrace ® RC Delivery System
Conmed Corporation
Orthopedic
54d
Cleared
Apr 05, 2013
ACCUMESH DEPLOYMENT SYSTEM
Covidien, LLC
General & Plastic Surgery
15d
Cleared
Oct 16, 2012
ACCUMESH DEPLOYMENT SYSTEM
Covidien, LLC
General & Plastic Surgery
15d
Cleared
May 02, 2012
ACCUMESH DEPLOYMENT SYSTEM
Covidien, LLC
General & Plastic Surgery
16d
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 General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →