FDA product code QXB: Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia
QXB is the FDA product code for drug coated prostatic dilation catheter for benign prostatic hyperplasia. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under QXB reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
dilate prostatic urethra to treat obstructive urinary symptoms associated with benign prostatic hyperplasia
Classification
| Field | Value |
|---|---|
| Device name | Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QXB devices
openFDA lists no recalls for product code QXB.
Frequently asked questions
What is FDA product code QXB?
QXB is the FDA product code for drug coated prostatic dilation catheter for benign prostatic hyperplasia. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is QXB?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QXB
- Run a recall and safety report across every QXB manufacturer
- Watch product code QXB 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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