FDA product code PHT: Basin For Endoscope Reprocessing
PHT is the FDA product code for basin for endoscope reprocessing. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. Devices under PHT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
To allow endoscopes to soak in reprocessing solutions.
Classification
| Field | Value |
|---|---|
| Device name | Basin For Endoscope Reprocessing |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for PHT devices
openFDA lists no recalls for product code PHT.
Frequently asked questions
What is FDA product code PHT?
PHT is the FDA product code for basin for endoscope reprocessing. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is PHT?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PHT
- Run a recall and safety report across every PHT manufacturer
- Watch product code PHT 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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