Collagen Surgical Mesh Containing Drugs
The Collagen Surgical Mesh Containing Drugs is a biologic-device combination product used for the reinforcement of soft tissue where weakness or defects exist, providing structural support during healing. It is an FDA Class 2 device regulated under 21 CFR 878.3300, requiring 510(k) clearance, within the General and Plastic Surgery (SU) medical specialty. The product code is PIJ, and it is flagged as an implant. This device is not life-sustaining.
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Basic Information
- Product Code
- PIJ
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
Reinforcement of soft tissue where weakness exists.
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 |
|---|---|---|---|---|
| K162193 | XenMatrix AB Surgical Graft | Dec 23, 2016 | Substantially Equivalent | C. R. Bard |
| K151177 | XenMatrix AB Surgical Graft | Jul 30, 2015 | Substantially Equivalent | C. R. Bard |
| K133223 | XENMATRIX AB SURGICAL GRAFT | Sep 19, 2014 | Substantially Equivalent | C.R. Bard, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.