FDA product code PIH: Urethral Insert With Pump For Bladder Drainage
PIH is the FDA product code for urethral insert with pump for bladder drainage. It is a Class II device, regulated under 21 CFR 876.5140 and reviewed by the Gastroenterology and Urology panel. Devices under PIH reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
The device is intended to empty urine from the bladder under patient control.
Classification
| Field | Value |
|---|---|
| Device name | Urethral Insert With Pump For Bladder Drainage |
| Device class | Class II |
| Regulation | 21 CFR 876.5140 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for PIH devices
openFDA lists no recalls for product code PIH.
Frequently asked questions
What is FDA product code PIH?
PIH is the FDA product code for urethral insert with pump for bladder drainage. It is a Class II device, regulated under 21 CFR 876.5140 and reviewed by the Gastroenterology and Urology panel.
What device class is PIH?
Class II, regulation 21 CFR 876.5140. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PIH
- Run a recall and safety report across every PIH manufacturer
- Watch product code PIH 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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