FDA product code FDL: Wristlet, Patient Return
FDL is the FDA product code for wristlet, patient return. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. Devices under FDL reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Wristlet, Patient Return |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for FDL devices
openFDA lists no recalls for product code FDL.
Frequently asked questions
What is FDA product code FDL?
FDL is the FDA product code for wristlet, patient return. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is FDL?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code FDL
- Run a recall and safety report across every FDL manufacturer
- Watch product code FDL 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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