PIJ — Collagen Surgical Mesh Containing Drugs Class II
FDA product code PIJ covers "Collagen Surgical Mesh Containing Drugs", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PIJ
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Reinforcement of soft tissue where weakness exists.