ORQ — Mesh, Surgical, Deployer Class II
FDA product code ORQ covers "Mesh, Surgical, Deployer", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ORQ
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250395 | conmed corporation | BioBrace ® RC Delivery System | April 7, 2025 |
| K130782 | covidien | ACCUMESH DEPLOYMENT SYSTEM | April 5, 2013 |
| K123066 | covidien | ACCUMESH DEPLOYMENT SYSTEM | October 16, 2012 |
| K121139 | covidien | ACCUMESH DEPLOYMENT SYSTEM | May 2, 2012 |
| K103269 | polytouch medical | PATCHASSIST LARGE | November 23, 2010 |
| K101218 | polytouch medical | PATCHASSIST | June 17, 2010 |