FDA product code KYQ: Kit, Chemical Snake-Bite
KYQ is the FDA product code for kit, chemical snake-bite. It is a Class III device, regulated under 21 CFR 880.5760 and reviewed by the General Hospital panel. Devices under KYQ reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Kit, Chemical Snake-Bite |
| Device class | Class III |
| Regulation | 21 CFR 880.5760 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | PMA |
Recalls for KYQ devices
openFDA lists no recalls for product code KYQ.
Frequently asked questions
What is FDA product code KYQ?
KYQ is the FDA product code for kit, chemical snake-bite. It is a Class III device, regulated under 21 CFR 880.5760 and reviewed by the General Hospital panel.
What device class is KYQ?
Class III, regulation 21 CFR 880.5760. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KYQ
- Run a recall and safety report across every KYQ manufacturer
- Watch product code KYQ 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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