FDA product code PLJ: Tissue Adhesive Internal Use
PLJ is the FDA product code for tissue adhesive internal use. It is a Class III device, regulated under 21 CFR 878.4010 and reviewed by the General and Plastic Surgery panel. Devices under PLJ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Intended for the fixation of surgical meshes.
Classification
| Field | Value |
|---|---|
| Device name | Tissue Adhesive Internal Use |
| Device class | Class III |
| Regulation | 21 CFR 878.4010 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PLJ devices
openFDA lists no recalls for product code PLJ.
Frequently asked questions
What is FDA product code PLJ?
PLJ is the FDA product code for tissue adhesive internal use. It is a Class III device, regulated under 21 CFR 878.4010 and reviewed by the General and Plastic Surgery panel.
What device class is PLJ?
Class III, regulation 21 CFR 878.4010. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PLJ
- Run a recall and safety report across every PLJ manufacturer
- Watch product code PLJ 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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