FDA product code PXP: Breast Biopsy / Localization Tray

PXP is the FDA product code for breast biopsy / localization tray. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. Devices under PXP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 8 recalls for PXP devices, 6 initiated in the last five years.

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

Recalls for PXP devices

8 product recalls in 7 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2024-04-08.

Frequently asked questions

What is FDA product code PXP?

PXP is the FDA product code for breast biopsy / localization 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 PXP?

Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.

Have PXP devices been recalled?

Yes: 8 product recalls across 7 recall events; the most recent began 2024-04-08.

Next steps

• Run an FDA pathway report with predicate devices for product code PXP
• Run a recall and safety report across every PXP manufacturer
• Watch product code PXP 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.

All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times