OXE — Mesh, Surgical, Collagen, Staple Line Reinforcement Class II
FDA product code OXE covers "Mesh, Surgical, Collagen, Staple Line Reinforcement", 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 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OXE
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K170945 | cook biotech incorporated | Biodesign Staple Line Reinforcement | April 28, 2017 |
| K153364 | kerecis limited | Kerecis SecureMesh | August 19, 2016 |
| K030879 | synovis surgical innovations | VERITAS COLLAGEN MATRIX | April 24, 2003 |
| K022044 | cook biotech | SURGISIS STAPLE LINE REINFORCEMENT | August 23, 2002 |