FDA product code FQK: Binder, Perineal
FQK is the FDA product code for binder, perineal. It is a Class I device, regulated under 21 CFR 880.5160 and reviewed by the General Hospital panel. Devices under FQK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Binder, Perineal |
| Device class | Class I |
| Regulation | 21 CFR 880.5160 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for FQK devices
openFDA lists no recalls for product code FQK.
Frequently asked questions
What is FDA product code FQK?
FQK is the FDA product code for binder, perineal. It is a Class I device, regulated under 21 CFR 880.5160 and reviewed by the General Hospital panel.
What device class is FQK?
Class I, regulation 21 CFR 880.5160. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FQK
- Run a recall and safety report across every FQK manufacturer
- Watch product code FQK 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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