FDA product code QGZ: Electrical Tumor Treatment Fields

QGZ is the FDA product code for electrical tumor treatment fields. It is a Class III device, reviewed by the Anesthesiology panel. Devices under QGZ reach the market by Unclassified; FDA lists no cleared 510(k)s for it.

Definition

The device is intended to treat patients with inoperable malignant pleural mesothelioma (MPM) concurrent to chemotherapy.

Classification

FieldValue
Device nameElectrical Tumor Treatment Fields
Device classClass III
Review panelAN — Anesthesiology
Medical specialtyUnknown
Premarket routeUnclassified
Life-sustaining or supportingYes

Recalls for QGZ devices

openFDA lists no recalls for product code QGZ.

Frequently asked questions

What is FDA product code QGZ?

QGZ is the FDA product code for electrical tumor treatment fields. It is a Class III device, reviewed by the Anesthesiology panel.

What device class is QGZ?

Class III. Typical premarket route: Unclassified.

Next steps

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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