Mesh, Surgical, Collagen, Staple Line Reinforcement
The Mesh, Surgical, Collagen, Staple Line Reinforcement is a collagen-based 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 OXE, 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
- OXE
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K170945 | Biodesign Staple Line Reinforcement | Apr 28, 2017 | Substantially Equivalent | Cook Biotech Incorporated |
| K153364 | Kerecis SecureMesh | Aug 19, 2016 | Substantially Equivalent | Kerecis Limited |
| K030879 | VERITAS COLLAGEN MATRIX | Apr 24, 2003 | Substantially Equivalent | Synovis Surgical Innovations |
| K022044 | SURGISIS STAPLE LINE REINFORCEMENT | Aug 23, 2002 | Substantially Equivalent | Cook Biotech, Inc. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.