FDA product code PXV: General Purpose Instrument Tray
PXV is the FDA product code for general purpose instrument tray. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. Devices under PXV 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 | General Purpose Instrument Tray |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for PXV devices
openFDA lists no recalls for product code PXV.
Frequently asked questions
What is FDA product code PXV?
PXV is the FDA product code for general purpose instrument tray. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is PXV?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PXV
- Run a recall and safety report across every PXV manufacturer
- Watch product code PXV 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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