FDA product code FLH: Washer Of Body Waste Receptacles
FLH is the FDA product code for washer of body waste receptacles. It is a Class I device, regulated under 21 CFR 880.6800 and reviewed by the General Hospital panel. Devices under FLH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Washer Of Body Waste Receptacles |
| Device class | Class I |
| Regulation | 21 CFR 880.6800 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for FLH devices
openFDA lists no recalls for product code FLH.
Frequently asked questions
What is FDA product code FLH?
FLH is the FDA product code for washer of body waste receptacles. It is a Class I device, regulated under 21 CFR 880.6800 and reviewed by the General Hospital panel.
What device class is FLH?
Class I, regulation 21 CFR 880.6800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FLH
- Run a recall and safety report across every FLH manufacturer
- Watch product code FLH 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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