OQL — Mesh, Surgical, Deployment Balloon Class II
FDA product code OQL covers "Mesh, Surgical, Deployment Balloon", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OQL
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K092726 | surgical structures | MESH GPS - LARGE, SMALL, SM, SM SMALL | March 15, 2010 |