FDA product code NKN: Syringe, Piston, Reprocessed
NKN is the FDA product code for syringe, piston, reprocessed. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. Devices under NKN reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Syringe, Piston, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for NKN devices
openFDA lists no recalls for product code NKN.
Frequently asked questions
What is FDA product code NKN?
NKN is the FDA product code for syringe, piston, reprocessed. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is NKN?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NKN
- Run a recall and safety report across every NKN manufacturer
- Watch product code NKN 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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