FDA product code PVX: Vaginal Examination Tray

PVX is the FDA product code for vaginal examination tray. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. Devices under PVX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for PVX devices, 1 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 PVX devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-02.

Frequently asked questions

What is FDA product code PVX?

PVX is the FDA product code for vaginal examination tray. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.

What device class is PVX?

Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.

Have PVX devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2022-11-02.

Next steps

• Run an FDA pathway report with predicate devices for product code PVX
• Run a recall and safety report across every PVX manufacturer
• Watch product code PVX 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 Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times