FDA product code FHK: Spreader, Bladder Neck
FHK is the FDA product code for spreader, bladder neck. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. Devices under FHK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Spreader, Bladder Neck |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for FHK devices
openFDA lists no recalls for product code FHK.
Frequently asked questions
What is FDA product code FHK?
FHK is the FDA product code for spreader, bladder neck. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FHK?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FHK
- Run a recall and safety report across every FHK manufacturer
- Watch product code FHK 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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