ORQ · Mesh, Surgical, Deployer
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | ORQ |
|---|---|
| Device Name | Mesh, Surgical, Deployer |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250395 | BioBrace ® RC Delivery System | Conmed Corporation | Apr 7, 2025 | SESE |
| K130782 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | Apr 5, 2013 | SESE |
| K123066 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | Oct 16, 2012 | SESE |
| K121139 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | May 2, 2012 | SESE |
| K103269 | PATCHASSIST LARGE | Polytouch Medical, Ltd. | Nov 23, 2010 | SESE |
| K101218 | PATCHASSIST | Polytouch Medical, Ltd. | Jun 17, 2010 | SESE |
Top Applicants
- Covidien, LLC — 3 clearances
- Polytouch Medical, Ltd. — 2 clearances
- Conmed Corporation — 1 clearance
