FDA product code PIJ: Collagen Surgical Mesh Containing Drugs
PIJ is the FDA product code for collagen surgical mesh containing drugs. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under PIJ, from 2 different applicants. The average 510(k) review took 188 days (median 141).
Definition
Reinforcement of soft tissue where weakness exists.
Classification
| Field | Value |
|---|---|
| Device name | Collagen Surgical Mesh Containing Drugs |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every PIJ clearance
Top PIJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C. R. Bard | 2 | 2016-12-23 |
| C.R. Bard, Inc. | 1 | 2014-09-19 |
Most recent PIJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162193 | C. R. Bard | XenMatrix AB Surgical Graft | 2016-12-23 | 141 |
| K151177 | C. R. Bard | XenMatrix AB Surgical Graft | 2015-07-30 | 90 |
| K133223 | C.R. Bard, Inc. | XENMATRIX AB SURGICAL GRAFT | 2014-09-19 | 333 |
Recalls for PIJ devices
openFDA lists no recalls for product code PIJ.
Frequently asked questions
What is FDA product code PIJ?
PIJ is the FDA product code for collagen surgical mesh containing drugs. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel.
What device class is PIJ?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIJ?
Across 3 cleared submissions the average was 188 days from receipt to decision (median 141).
Which companies have the most PIJ clearances?
C. R. Bard (2); C.R. Bard, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PIJ
- Run a recall and safety report across every PIJ manufacturer
- Watch product code PIJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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