OQL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mesh, Surgical, Deployment Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- FDA definition
- The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| MESH GPS - LARGE, SMALL, SM, SM SMALL (K092726) | Surgical Structures , Ltd. | 2010-03-15 | + Add |
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Every clearance here is in the API, with alerts when new ones post.