Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
The Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement is a non-absorbable surgical mesh implant used for reinforcement of soft tissue where weakness exists during staple line reinforcement procedures. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OXD, with regulation number 878.3300 under the General, Plastic Surgery medical specialty, and it carries an implant flag.
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Basic Information
- Product Code
- OXD
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K010936 | MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | May 21, 2001 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K001789 | SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | Jul 06, 2000 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K955364 | SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | Feb 01, 1996 | Substantially Equivalent | W. L. Gore & Associates, Inc. |