OXD — Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement Class II
FDA product code OXD covers "Mesh, Surgical, Non-Absorbable, 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 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OXD
- 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 |
|---|---|---|---|
| K010936 | w. l. gore and associates | MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | May 21, 2001 |
| K001789 | w. l. gore and associates | SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | July 6, 2000 |
| K955364 | w. l. gore and associates | SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | February 1, 1996 |