FDA product code ODH: Implantable Bladder-Evacuation Electrical Stimulation System
ODH is the FDA product code for implantable bladder-evacuation electrical stimulation system. It is a HDE device, reviewed by the Gastroenterology and Urology panel. Devices under ODH reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
To provide urination on demand and to reduce post-void residual volumes of urine in patients who have clinically complete spinal cord lesions (asia classification) with intact parasympathetic innervations of the bladder and are skeletally mature and neurologically stable.
Classification
| Field | Value |
|---|---|
| Device name | Implantable Bladder-Evacuation Electrical Stimulation System |
| Device class | HDE |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for ODH devices
openFDA lists no recalls for product code ODH.
Frequently asked questions
What is FDA product code ODH?
ODH is the FDA product code for implantable bladder-evacuation electrical stimulation system. It is a HDE device, reviewed by the Gastroenterology and Urology panel.
What device class is ODH?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code ODH
- Run a recall and safety report across every ODH manufacturer
- Watch product code ODH 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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