FDA product code ORQ: Mesh, Surgical, Deployer
ORQ is the FDA product code for mesh, surgical, deployer. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under ORQ, 1 in the last five years, from 3 different applicants. The average 510(k) review took 28 days (median 18); 54 days on average over the last three years.
Definition
Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Deployer |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for ORQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 54 |
Compare with all 510(k) review times · Search every ORQ clearance
Top ORQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Covidien, LLC | 3 | 2013-04-05 |
| Polytouch Medical, Ltd. | 2 | 2010-11-23 |
| Conmed Corporation | 1 | 2025-04-07 |
Most recent ORQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250395 | Conmed Corporation | BioBrace ® RC Delivery System | 2025-04-07 | 54 |
| K130782 | Covidien, LLC | ACCUMESH DEPLOYMENT SYSTEM | 2013-04-05 | 15 |
| K123066 | Covidien, LLC | ACCUMESH DEPLOYMENT SYSTEM | 2012-10-16 | 15 |
| K121139 | Covidien, LLC | ACCUMESH DEPLOYMENT SYSTEM | 2012-05-02 | 16 |
| K103269 | Polytouch Medical, Ltd. | PATCHASSIST LARGE | 2010-11-23 | 19 |
Recalls for ORQ devices
openFDA lists no recalls for product code ORQ.
Frequently asked questions
What is FDA product code ORQ?
ORQ is the FDA product code for mesh, surgical, deployer. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel.
What device class is ORQ?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code ORQ?
Across 6 cleared submissions the average was 28 days from receipt to decision (median 18).
Which companies have the most ORQ clearances?
Covidien, LLC (3); Polytouch Medical, Ltd. (2); Conmed Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ORQ
- Run a recall and safety report across every ORQ manufacturer
- Watch product code ORQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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