FDA product code PJK: Tissue Adhesive For Internal Use
PJK is the FDA product code for tissue adhesive for 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 PJK reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.
Classification
| Field | Value |
|---|---|
| Device name | Tissue Adhesive For 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 PJK devices
openFDA lists no recalls for product code PJK.
Frequently asked questions
What is FDA product code PJK?
PJK is the FDA product code for tissue adhesive for 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 PJK?
Class III, regulation 21 CFR 878.4010. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PJK
- Run a recall and safety report across every PJK manufacturer
- Watch product code PJK 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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