ORQ
- Product code
- ORQ
- Device name
- Mesh, Surgical, Deployer
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 6 (all years; only the last 3 years are listed here)
FDA classification 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) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250395 | 2025-04-07 | Conmed Corporation | BioBrace ® RC Delivery System |
Official FDA classification page: ORQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).