FDA product code QXR: Vaginal Hydrogel Packing System
QXR is the FDA product code for vaginal hydrogel packing system. It is a Class II device, regulated under 21 CFR 892.5735 and reviewed by the Radiology panel. Devices under QXR reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. The device is intended to reduce the radiation dose delivered to adjacent pelvic organs by temporarily displacing the vaginal wall and adjacent pelvic tissues during radiation therapy treatment planning and delivery.
Classification
| Field | Value |
|---|---|
| Device name | Vaginal Hydrogel Packing System |
| Device class | Class II |
| Regulation | 21 CFR 892.5735 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Recalls for QXR devices
openFDA lists no recalls for product code QXR.
Frequently asked questions
What is FDA product code QXR?
QXR is the FDA product code for vaginal hydrogel packing system. It is a Class II device, regulated under 21 CFR 892.5735 and reviewed by the Radiology panel.
What device class is QXR?
Class II, regulation 21 CFR 892.5735. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QXR
- Run a recall and safety report across every QXR manufacturer
- Watch product code QXR 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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