FDA product code FHL: Scoop
FHL is the FDA product code for scoop. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. Devices under FHL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Scoop |
| 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 FHL devices
openFDA lists no recalls for product code FHL.
Frequently asked questions
What is FDA product code FHL?
FHL is the FDA product code for scoop. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FHL?
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 FHL
- Run a recall and safety report across every FHL manufacturer
- Watch product code FHL 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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