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)
- 6
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).