FDA product code QPT: Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence
QPT is the FDA product code for stimulator, tibial, electrical, implantable, for urinary incontinence. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under QPT reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Definition
Implanted electrical stimulator, including implanted power source, for treatment of overactive bladder or symptoms of overactive bladder through electrical stimulation of the tibial nerve.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QPT devices
openFDA lists no recalls for product code QPT.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month
Frequently asked questions
What is FDA product code QPT?
QPT is the FDA product code for stimulator, tibial, electrical, implantable, for urinary incontinence. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is QPT?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QPT
- Run a recall and safety report across every QPT manufacturer
- Watch product code QPT 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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