FDA product code PXY: Irrigation Kit (Wounds)
PXY is the FDA product code for irrigation kit (wounds). It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General and Plastic Surgery panel. Devices under PXY 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 | Irrigation Kit (Wounds) |
| 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 PXY devices
openFDA lists no recalls for product code PXY.
Frequently asked questions
What is FDA product code PXY?
PXY is the FDA product code for irrigation kit (wounds). 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 PXY?
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 PXY
- Run a recall and safety report across every PXY manufacturer
- Watch product code PXY 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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