Mesh, Surgical, Deployer
The Mesh, Surgical, Deployer (product code ORQ) is a device intended to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects such as hernias. It functions as a deployment tool for surgical mesh in minimally invasive procedures and is not itself implanted. As an FDA Class 2 device under regulation 878.3300, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.
Basic Information
- Product Code
- ORQ
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250395 | BioBrace ® RC Delivery System | Apr 07, 2025 | Substantially Equivalent | CONMED Corporation |
| K130782 | ACCUMESH DEPLOYMENT SYSTEM | Apr 05, 2013 | Substantially Equivalent | Covidien LLC |
| K123066 | ACCUMESH DEPLOYMENT SYSTEM | Oct 16, 2012 | Substantially Equivalent | Covidien LLC |
| K121139 | ACCUMESH DEPLOYMENT SYSTEM | May 02, 2012 | Substantially Equivalent | Covidien LLC |
| K103269 | PATCHASSIST LARGE | Nov 23, 2010 | Substantially Equivalent | POLYTOUCH MEDICAL LTD |
| K101218 | PATCHASSIST | Jun 17, 2010 | Substantially Equivalent | POLYTOUCH MEDICAL LTD |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.