Product code OXE
- Device name
- Mesh, Surgical, Collagen, Staple Line Reinforcement
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170945 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2017-04-28 |
| K153364 | Kerecis SecureMesh | Kerecis Limited | 2016-08-19 |
| K030879 | VERITAS COLLAGEN MATRIX | Synovis Surgical Innovations | 2003-04-24 |
| K022044 | SURGISIS STAPLE LINE REINFORCEMENT | Cook Biotech, Inc. | 2002-08-23 |
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