FDA product code PYJ: Ulcer Wound Tray
PYJ is the FDA product code for ulcer wound tray. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General and Plastic Surgery panel. Devices under PYJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Ulcer Wound Tray |
| Device class | Class I |
| Regulation | 21 CFR 878.4014 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for PYJ devices
openFDA lists no recalls for product code PYJ.
Frequently asked questions
What is FDA product code PYJ?
PYJ is the FDA product code for ulcer wound tray. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General and Plastic Surgery panel.
What device class is PYJ?
Class I, regulation 21 CFR 878.4014. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PYJ
- Run a recall and safety report across every PYJ manufacturer
- Watch product code PYJ 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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